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A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents (DIONE)

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: NCT00915655
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : December 28, 2011
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: darunavir
Drug: ritonavir
Drug: zidovudine
Drug: lamivudine
Drug: abacavir
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DRV/Rtv
Hide Arm/Group Description Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
Period Title: Overall Study
Started 12
Completed 12 [1]
Not Completed 0
[1]
'Completed' represents patients who have not discontinued at time of cut-off for Week 24 analysis
Arm/Group Title DRV/Rtv
Hide Arm/Group Description Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
14.7  (1.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
8
  66.7%
Male
4
  33.3%
Percentile for Height  
Median (Full Range)
Unit of measure:  Height Percentile
Number Analyzed 12 participants
27.2
(0.5 to 94.1)
Percentile for BMI  
Median (Full Range)
Unit of measure:  BMI Percentile
Number Analyzed 12 participants
47.5
(13.3 to 85.9)
Percentile for Weight  
Median (Full Range)
Unit of measure:  Weight Percentile
Number Analyzed 12 participants
51.6
(8.6 to 79.0)
1.Primary Outcome
Title Virological Response[Viral Load <50 Copies/mL, TLOVR]
Hide Description The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load <50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was considered the primary efficacy analysis set.
Arm/Group Title DRV/Rtv
Hide Arm/Group Description:
Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
Yes 11
No 1
2.Secondary Outcome
Title Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]
Hide Description The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) patients who had >=50 copies/mL in the Week-24 window, b) patients who discontinued prior to Week 24 for lack or loss of efficacy, c) patients who had a switch in their background regimen that was not permitted by the protocol, and d) patients who discontinued for reasons other than adverse events (AEs)/death, and lack or loss of efficacy (provided their last available viral load was detectable).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was considered the primary efficacy analysis set.
Arm/Group Title DRV/Rtv
Hide Arm/Group Description:
Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
12
Time Frame [Not Specified]
Adverse Event Reporting Description Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
 
Arm/Group Title DRV/Rtv
Hide Arm/Group Description Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
All-Cause Mortality
DRV/Rtv
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
DRV/Rtv
Affected / at Risk (%)
Total   3/12 (25.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  2/12 (16.67%) 
Neutropenia * 1  1/12 (8.33%) 
Reproductive system and breast disorders   
Cervical dysplasia * 1  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DRV/Rtv
Affected / at Risk (%)
Total   11/12 (91.67%) 
Blood and lymphatic system disorders   
Anaemia * 1  3/12 (25.00%) 
Leukopenia * 1  1/12 (8.33%) 
Neutropenia * 1  1/12 (8.33%) 
Eye disorders   
Conjunctival hyperaemia * 1  1/12 (8.33%) 
Conjunctivitis allergic * 1  1/12 (8.33%) 
Keratitis * 1  1/12 (8.33%) 
Vision blurred * 1  1/12 (8.33%) 
Gastrointestinal disorders   
Nausea * 1  3/12 (25.00%) 
Vomiting * 1  3/12 (25.00%) 
Diarrhoea * 1  2/12 (16.67%) 
Abdominal pain * 1  1/12 (8.33%) 
General disorders   
Pyrexia * 1  2/12 (16.67%) 
Infections and infestations   
Furuncle * 1  2/12 (16.67%) 
Sinusitis * 1  2/12 (16.67%) 
Asymptomatic bacteriuria * 1  1/12 (8.33%) 
Bronchitis * 1  1/12 (8.33%) 
Herpes simplex * 1  1/12 (8.33%) 
Herpes zoster * 1  1/12 (8.33%) 
Otitis media acute * 1  1/12 (8.33%) 
Upper respiratory tract infection * 1  1/12 (8.33%) 
Injury, poisoning and procedural complications   
Limb injury * 1  1/12 (8.33%) 
Nail injury * 1  1/12 (8.33%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/12 (8.33%) 
Nervous system disorders   
Dizziness * 1  1/12 (8.33%) 
Psychiatric disorders   
Attention deficit/hyperactivity disorder * 1  1/12 (8.33%) 
Reproductive system and breast disorders   
Uterine cervical erosion * 1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/12 (16.67%) 
Rhinitis allergic * 1  1/12 (8.33%) 
Rhinorrhoea * 1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/12 (8.33%) 
Rash * 1  1/12 (8.33%) 
Vascular disorders   
Hypotension * 1  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Sponsor will not unreasonably withhold consent to publish the data generated in this trial. However, it is the policy of the Sponsor not to allow the investigators to publish their results or findings prior to the Sponsor’s publication of the overall trial results. The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the Sponsor to review the prepublication manuscript prior to submission of the manuscript to the publisher.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: +1 609 730-7548
Layout table for additonal information
Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00915655    
Other Study ID Numbers: CR016312
TMC114-TiDP29-C230 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
2008-004631-37 ( EudraCT Number )
First Submitted: June 4, 2009
First Posted: June 8, 2009
Results First Submitted: November 25, 2011
Results First Posted: December 28, 2011
Last Update Posted: September 3, 2012