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Trial record 20 of 126 for:    HSV-2

HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding (VIP)

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: NCT00530777
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : April 18, 2012
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
Royalty Research Fund - University of Washington
Puget Sound Partners for Global Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carey Farquhar, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infections
Herpes Simplex
Interventions Drug: valacyclovir
Drug: placebo
Enrollment 148
Recruitment Details HIV-1 infected pregnant women seeking antenatal care at the Mathare North City Council Clinic in Nairobi Kenya, or referred from neighboring clinics, were recruited for study screening
Pre-assignment Details  
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Period Title: Overall Study
Started 74 74
Completed 67 69
Not Completed 7 5
Reason Not Completed
Lost to Follow-up             0             1
Death             1             2
Physician Decision             1             0
Withdrawal by Subject             0             1
Unable to adhere to visit schedule             5             1
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum oral placebo twice daily from 34 weeks gestation to 1 year postpartum Total of all reporting groups
Overall Number of Baseline Participants 74 74 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
<=18 years
3
   4.1%
4
   5.4%
7
   4.7%
Between 18 and 65 years
71
  95.9%
70
  94.6%
141
  95.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 74 participants 148 participants
26.2  (5.3) 26.0  (4.5) 26.1  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Female
74
 100.0%
74
 100.0%
148
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Kenya Number Analyzed 74 participants 74 participants 148 participants
74 74 148
1.Primary Outcome
Title Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation
Hide Description Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Women with paired plasma samples at 34 and 38 weeks gestation
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description:
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Overall Number of Participants Analyzed 51 49
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-0.53  (.074) 0.03  (0.76)
2.Secondary Outcome
Title Vertical HIV-1 Transmission
Hide Description Mother-to-child HIV transmission
Time Frame 1 year postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Note the sample size is 73 for each group rather than 74 due to loss to follow-up.
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description:
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: Participants
6 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum oral placebo twice daily from 34 weeks gestation to 1 year postpartum
All-Cause Mortality
Valacyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Valacyclovir Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/74 (1.35%)      2/74 (2.70%)    
Investigations     
Death *  1/1 (100.00%)  1 2/2 (100.00%)  2
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valacyclovir Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/74 (0.00%)      0/74 (0.00%)    
Unable to evaluate the effect of valacyclovir on mother-to-child HIV transmission (MTCT) or on change in HIV-1 RNA among women eligible for highly active antiretroviral therapy (HAART); lack power to detect association between treatment and MTCT.
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: Dr. Carey Farquhar
Organization: University of Washington
Phone: 206-543-4278
EMail: cfarq@uw.edu
Publications:
Whitehead S, Bollen L, Leelawiwat W, et al. Maternal HSV-2 Cervicovaginal Shedding Increases the Risk of Intra-partum HIV-1 Transmission. 14th Conference on Retroviruses and Opportunistic Infections. Los Angeles, 2007.
Layout table for additonal information
Responsible Party: Carey Farquhar, University of Washington
ClinicalTrials.gov Identifier: NCT00530777     History of Changes
Other Study ID Numbers: 32462
07-7306-A01
R03HD057773 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2007
First Posted: September 17, 2007
Results First Submitted: March 22, 2012
Results First Posted: April 18, 2012
Last Update Posted: December 19, 2018