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Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis (TMC278LA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02165202
Recruitment Status : Completed
First Posted : June 17, 2014
Results First Posted : July 26, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Human Immunodeficiency Virus (HIV)
Interventions Drug: Rilpivirine
Drug: Placebo
Enrollment 136
Recruitment Details  
Pre-assignment Details Participants will be randomized to either the active product regimen or the placebo arm at enrollment. Participants randomized to active and placebo product will first be prescribed oral TMC278 (rilpivirine) 25 mg capsule and oral placebo capsule, once daily for four weeks as an oral run-in and then will receive IM injections at week 4.
Arm/Group Title Rilpivirine Placebo
Hide Arm/Group Description

Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).

Rilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™).

Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).

Placebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.

Period Title: Oral Phase
Started 91 [1] 45 [1]
Completed [2] 80 42
Not Completed 11 3
Reason Not Completed
Refused further participation             5             1
Study product Related Toxicity             1             0
Unable to contact Participant             1             1
Clinical reasons             1             0
QTcF>500 ms or increase of>60 ms             1             0
CMC advised termination             1             0
Relocated, no follow-up planned             1             0
Abnormal EKG             0             1
[1]
Participants Enrolled in the study
[2]
Participants who completed oral run in phase (0-week 4) and received at least 1 injection.
Period Title: Injection Phase
Started 80 [1] 42 [1]
Completed [2] 70 36
Not Completed 10 6
Reason Not Completed
Abnormal Lab Value             5             1
Reactive HIV or HIV Suspected             0             2
Unable to attend within Visit Window             1             0
QTcF>500 ms or increase of>60 ms             0             1
End of Study             2             1
Study Product related Toxicity             1             0
No longer interested             0             1
Participant unwilling to comply             1             0
[1]
Participants who received at least one injection.
[2]
Ppts who received at least 1 injection but were not discontinued or terminated till the end of study
Arm/Group Title Rilpivirine Placebo Total
Hide Arm/Group Description

Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).

Rilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™).

Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).

Placebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.

Total of all reporting groups
Overall Number of Baseline Participants 91 45 136
Hide Baseline Analysis Population Description
This template shows demographic characteristics of participants measured at Enrollment in the study.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 91 participants 45 participants 136 participants
31
(26 to 36)
30
(25 to 39)
31
(25 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 45 participants 136 participants
Female
91
 100.0%
45
 100.0%
136
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 45 participants 136 participants
Hispanic or Latino
6
   6.6%
3
   6.7%
9
   6.6%
Not Hispanic or Latino
85
  93.4%
42
  93.3%
127
  93.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 45 participants 136 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.1%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
86
  94.5%
42
  93.3%
128
  94.1%
White
3
   3.3%
0
   0.0%
3
   2.2%
More than one race
0
   0.0%
1
   2.2%
1
   0.7%
Unknown or Not Reported
1
   1.1%
2
   4.4%
3
   2.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 91 participants 45 participants 136 participants
24
  26.4%
12
  26.7%
36
  26.5%
Zimbabwe Number Analyzed 91 participants 45 participants 136 participants
35
  38.5%
17
  37.8%
52
  38.2%
South Africa Number Analyzed 91 participants 45 participants 136 participants
32
  35.2%
16
  35.6%
48
  35.3%
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
18-25 Number Analyzed 91 participants 45 participants 136 participants
22
  24.2%
14
  31.1%
36
  26.5%
26-35 Number Analyzed 91 participants 45 participants 136 participants
45
  49.5%
14
  31.1%
59
  43.4%
36-45 Number Analyzed 91 participants 45 participants 136 participants
24
  26.4%
17
  37.8%
41
  30.1%
Height  
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 91 participants 45 participants 136 participants
159
(153 to 165)
158
(152 to 165)
158
(153 to 165)
Weight   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 90 participants 45 participants 135 participants
76
(67 to 89)
73
(63 to 88)
75
(64 to 89)
[1]
Measure Analysis Population Description: 1 participant was missing weight measurement
BMI   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 90 participants 45 participants 135 participants
31
(26 to 35)
29
(27 to 35)
30
(27 to 35)
[1]
Measure Analysis Population Description: 1 participant was missing BMI
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 45 participants 136 participants
Married/civil union/legal partnership
45
  49.5%
18
  40.0%
63
  46.3%
Living with primary or main partner
5
   5.5%
2
   4.4%
7
   5.1%
Have primary or main partner, not living
15
  16.5%
6
  13.3%
21
  15.4%
Single/divorced/widowed
26
  28.6%
19
  42.2%
45
  33.1%
Other
0
   0.0%
0
   0.0%
0
   0.0%
Employment Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 45 participants 136 participants
Not employed
60
  65.9%
22
  48.9%
82
  60.3%
Part-time employment
17
  18.7%
14
  31.1%
31
  22.8%
Full-time employment
14
  15.4%
9
  20.0%
23
  16.9%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 45 participants 136 participants
No schooling
0
   0.0%
0
   0.0%
0
   0.0%
Primary school, not complete
16
  17.6%
11
  24.4%
27
  19.9%
Primary school, complete
58
  63.7%
27
  60.0%
85
  62.5%
Secondary school, not complete
7
   7.7%
3
   6.7%
10
   7.4%
Secondary school, complete
10
  11.0%
4
   8.9%
14
  10.3%
Technical training, not complete
0
   0.0%
0
   0.0%
0
   0.0%
Technical training, complete
0
   0.0%
0
   0.0%
0
   0.0%
College or university, not complete
0
   0.0%
0
   0.0%
0
   0.0%
College or university, complete
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase
Hide Description Number of participants experiencing any Grade 2 or higher clinical and laboratory AEs to evaluate the safety of the injectable product, TMC278 LA (1200 mg dose administered at Weeks 4, 12, 20, 28, 36 and 44), through 48 weeks after initial injection (at Week 52) in women in SSA and the US.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one injection and were followed up to 52 weeks are included in this analysis.
Arm/Group Title Rilpivirine Placebo
Hide Arm/Group Description:

Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).

Rilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™).

Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).

Placebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.

Overall Number of Participants Analyzed 80 42
Measure Type: Count of Participants
Unit of Measure: Participants
59
  73.8%
31
  73.8%
Time Frame Adverse Event data were collected from the time of enrollment to the end of the study. (From enrollment to week 76).
Adverse Event Reporting Description Adverse Event data that were collected during injection phase from the time of first injection to week 52 are included in the Report showing list of other AEs excluding Serious AEs. (From week 4 to week 52).
 
Arm/Group Title Rilpivirine Placebo
Hide Arm/Group Description

Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).

Rilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™).

Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).

Placebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.

All-Cause Mortality
Rilpivirine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/91 (1.10%)      0/45 (0.00%)    
Hide Serious Adverse Events
Rilpivirine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/91 (4.40%)      1/45 (2.22%)    
Gastrointestinal disorders     
Pancreatitis acute * 1  0/91 (0.00%)  0 1/45 (2.22%)  1
Pancreatitis * 1  0/91 (0.00%)  0 1/45 (2.22%)  1
Infections and infestations     
Gastroenteritis * 1  1/91 (1.10%)  1 0/45 (0.00%)  0
Injury, poisoning and procedural complications     
Overdose * 1  1/91 (1.10%)  1 0/45 (0.00%)  0
Radius fracture * 1  1/91 (1.10%)  1 0/45 (0.00%)  0
Pelvic fracture * 1  1/91 (1.10%)  1 0/45 (0.00%)  0
Nervous system disorders     
Haemorrhagic stroke * 1  1/91 (1.10%)  1 0/45 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis * 1  1/91 (1.10%)  1 0/45 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rilpivirine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/80 (100.00%)      40/42 (95.24%)    
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Cardiac disorders     
Arrhythmia * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Sinus arrhythmia * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Tachycardia * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Ear and labyrinth disorders     
Ear pain * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Ear pruritus * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Endocrine disorders     
Hyperthyroidism * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Eye disorders     
Chalazion * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Conjunctival haemorrhage * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Eye pruritus * 1  0/80 (0.00%)  0 2/42 (4.76%)  2
Visual acuity reduced * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Gastrointestinal disorders     
Abdominal pain * 1  4/80 (5.00%)  4 4/42 (9.52%)  4
Abdominal pain lower * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Abdominal pain upper * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Aphthous ulcer * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Constipation * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Diarrhoea * 1  3/80 (3.75%)  3 2/42 (4.76%)  2
Dyspepsia * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Gastritis * 1  3/80 (3.75%)  3 1/42 (2.38%)  1
Haemorrhoids * 1  1/80 (1.25%)  1 2/42 (4.76%)  2
Nausea * 1  1/80 (1.25%)  1 2/42 (4.76%)  2
Toothache * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Vomiting * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
General disorders     
Chest pain * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Fatigue * 1  2/80 (2.50%)  2 1/42 (2.38%)  1
Feeling hot * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Induration * 1  5/80 (6.25%)  5 0/42 (0.00%)  0
Influenza like illness * 1  2/80 (2.50%)  2 1/42 (2.38%)  1
Injection site discharge * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Injection site erythema * 1  20/80 (25.00%)  20 1/42 (2.38%)  1
Injection site granuloma * 1  4/80 (5.00%)  4 0/42 (0.00%)  0
Injection site haemorrhage * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Injection site induration * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Injection site inflammation * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Injection site mass * 1  6/80 (7.50%)  6 0/42 (0.00%)  0
Injection site nodule * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Injection site pain * 1  60/80 (75.00%)  60 17/42 (40.48%)  17
Injection site pruritus * 1  29/80 (36.25%)  29 5/42 (11.90%)  5
Injection site swelling * 1  29/80 (36.25%)  29 3/42 (7.14%)  3
Malaise * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Nodule * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Pain * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Pyrexia * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Hepatobiliary disorders     
Biliary colic * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Cholelithiasis * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Cholestasis * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Hepatic steatosis * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Immune system disorders     
Seasonal allergy * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Infections and infestations     
Bacterial vaginosis * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Body tinea * 1  1/80 (1.25%)  1 2/42 (4.76%)  2
Carbuncle * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Cellulitis * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Conjunctivitis * 1  2/80 (2.50%)  2 1/42 (2.38%)  1
Dermatophytosis * 1  0/80 (0.00%)  0 2/42 (4.76%)  2
Gastroenteritis * 1  6/80 (7.50%)  6 3/42 (7.14%)  3
Genital herpes * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Genitourinary chlamydia infection * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Groin abscess * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Helminthic infection * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Infected skin ulcer * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Influenza * 1  4/80 (5.00%)  4 2/42 (4.76%)  2
Injection site abscess * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Pelvic inflammatory disease * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Pharyngitis * 1  2/80 (2.50%)  2 2/42 (4.76%)  2
Pharyngitis bacterial * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Pharyngitis streptococcal * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Pneumonia * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Post procedural infection * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Respiratory tract infection * 1  9/80 (11.25%)  9 5/42 (11.90%)  5
Sinusitis * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Skin bacterial infection * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Tinea versicolour * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Tonsillitis * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Upper respiratory tract infection * 1  6/80 (7.50%)  6 6/42 (14.29%)  6
Upper respiratory tract infection bacterial * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Urinary tract infection * 1  7/80 (8.75%)  7 1/42 (2.38%)  1
Urinary tract infection bacterial * 1  3/80 (3.75%)  3 1/42 (2.38%)  1
Vaginal infection * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Viral upper respiratory tract infection * 1  2/80 (2.50%)  2 1/42 (2.38%)  1
Vulvovaginal candidiasis * 1  3/80 (3.75%)  3 3/42 (7.14%)  3
Vulvovaginitis trichomonal * 1  3/80 (3.75%)  3 2/42 (4.76%)  2
Injury, poisoning and procedural complications     
Arthropod bite * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Burns second degree * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Contusion * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Eye injury * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Injury * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Joint injury * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Laceration * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Ligament rupture * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Ligament sprain * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Limb injury * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Meniscus injury * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Post procedural swelling * 1  8/80 (10.00%)  8 2/42 (4.76%)  2
Procedural dizziness * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Procedural pain * 1  29/80 (36.25%)  29 5/42 (11.90%)  5
Skin abrasion * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Soft tissue injury * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Synovial rupture * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Investigations     
Alanine aminotransferase increased * 1  17/80 (21.25%)  17 4/42 (9.52%)  4
Aspartate aminotransferase increased * 1  14/80 (17.50%)  14 5/42 (11.90%)  5
Blood albumin decreased * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Blood alkaline phosphatase increased * 1  0/80 (0.00%)  0 2/42 (4.76%)  2
Blood bicarbonate decreased * 1  11/80 (13.75%)  11 4/42 (9.52%)  4
Blood bilirubin increased * 1  5/80 (6.25%)  5 5/42 (11.90%)  5
Blood calcium decreased * 1  8/80 (10.00%)  8 6/42 (14.29%)  6
Blood calcium increased * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Blood creatine phosphokinase increased * 1  10/80 (12.50%)  10 4/42 (9.52%)  4
Blood creatinine increased * 1  3/80 (3.75%)  3 3/42 (7.14%)  3
Blood glucose decreased * 1  21/80 (26.25%)  21 6/42 (14.29%)  6
Blood glucose increased * 1  19/80 (23.75%)  19 11/42 (26.19%)  11
Blood phosphorus decreased * 1  16/80 (20.00%)  16 14/42 (33.33%)  14
Blood pressure diastolic increased * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Blood pressure increased * 1  3/80 (3.75%)  3 2/42 (4.76%)  2
Body temperature increased * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Electrocardiogram PR prolongation * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Electrocardiogram QT prolonged * 1  2/80 (2.50%)  2 2/42 (4.76%)  2
Haemoglobin decreased * 1  3/80 (3.75%)  3 2/42 (4.76%)  2
Neutrophil count decreased * 1  2/80 (2.50%)  2 1/42 (2.38%)  1
Platelet count decreased * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Weight decreased * 1  8/80 (10.00%)  8 4/42 (9.52%)  4
White blood cell count decreased * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
White blood cells urine positive * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Metabolism and nutrition disorders     
Abnormal loss of weight * 1  3/80 (3.75%)  3 2/42 (4.76%)  2
Decreased appetite * 1  0/80 (0.00%)  0 2/42 (4.76%)  2
Hyperglycaemia * 1  3/80 (3.75%)  3 0/42 (0.00%)  0
Hypoalbuminaemia * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Hypocalcaemia * 1  0/80 (0.00%)  0 3/42 (7.14%)  3
Hypoglycaemia * 1  5/80 (6.25%)  5 0/42 (0.00%)  0
Hypokalaemia * 1  4/80 (5.00%)  4 2/42 (4.76%)  2
Hypophosphataemia * 1  6/80 (7.50%)  6 2/42 (4.76%)  2
Vitamin D deficiency * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  4/80 (5.00%)  4 3/42 (7.14%)  3
Back pain * 1  11/80 (13.75%)  11 7/42 (16.67%)  7
Costochondritis * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Flank pain * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Joint effusion * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Musculoskeletal pain * 1  3/80 (3.75%)  3 2/42 (4.76%)  2
Myalgia * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Pain in extremity * 1  2/80 (2.50%)  2 1/42 (2.38%)  1
Patellofemoral pain syndrome * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Vulvovaginal warts * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Nervous system disorders     
Dizziness * 1  5/80 (6.25%)  5 2/42 (4.76%)  2
Facial paralysis * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Headache * 1  16/80 (20.00%)  16 11/42 (26.19%)  11
Migraine * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Neuropathy peripheral * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Paraesthesia * 1  2/80 (2.50%)  2 1/42 (2.38%)  1
Tension headache * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Vomiting in pregnancy * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Psychiatric disorders     
Abnormal dreams * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Affect lability * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Insomnia * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Stress * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Terminal insomnia * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Renal and urinary disorders     
Dysuria * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Glycosuria * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Haematuria * 1  7/80 (8.75%)  7 6/42 (14.29%)  6
Pollakiuria * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Proteinuria * 1  21/80 (26.25%)  21 9/42 (21.43%)  9
Urinary incontinence * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Urinary retention * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Reproductive system and breast disorders     
Adnexa uteri pain * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Breast mass * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Breast pain * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Cervical dysplasia * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Cervix haemorrhage uterine * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Dysmenorrhoea * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Menometrorrhagia * 1  4/80 (5.00%)  4 1/42 (2.38%)  1
Menorrhagia * 1  5/80 (6.25%)  5 0/42 (0.00%)  0
Metrorrhagia * 1  5/80 (6.25%)  5 4/42 (9.52%)  4
Pelvic pain * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Vaginal discharge * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Vaginal haemorrhage * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Vaginal odour * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Vulvovaginal pruritus * 1  1/80 (1.25%)  1 1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Atelectasis * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Cough * 1  3/80 (3.75%)  3 0/42 (0.00%)  0
Dyspnoea * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Interstitial lung disease * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Nasal congestion * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Oropharyngeal pain * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Productive cough * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis * 1  1/80 (1.25%)  1 3/42 (7.14%)  3
Erythema * 1  4/80 (5.00%)  4 2/42 (4.76%)  2
Hyperhidrosis * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Hyperkeratosis * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Macule * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Night sweats * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Pruritus * 1  9/80 (11.25%)  9 0/42 (0.00%)  0
Psoriasis * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Rash macular * 1  2/80 (2.50%)  2 0/42 (0.00%)  0
Rash maculo-papular * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Rash papular * 1  1/80 (1.25%)  1 2/42 (4.76%)  2
Skin discolouration * 1  1/80 (1.25%)  1 0/42 (0.00%)  0
Skin ulcer * 1  0/80 (0.00%)  0 1/42 (2.38%)  1
Vascular disorders     
Hypertension * 1  3/80 (3.75%)  3 1/42 (2.38%)  1
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Heather Kelly
Organization: PATH
Phone: 650-392-2510
EMail: hkelly@path.org
Publications:
Layout table for additonal information
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02165202    
Other Study ID Numbers: HPTN 076
1015131 ( Other Grant/Funding Number: Bill & Melinda Gates Foundation (along with NIH for HPTN) )
UM1AI068619 ( U.S. NIH Grant/Contract )
First Submitted: May 21, 2014
First Posted: June 17, 2014
Results First Submitted: July 2, 2018
Results First Posted: July 26, 2018
Last Update Posted: August 27, 2018