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

This study has been completed.
Sponsor:
Collaborators:
Royalty Research Fund - University of Washington
Puget Sound Partners for Global Health
Information provided by (Responsible Party):
Carey Farquhar, University of Washington
ClinicalTrials.gov Identifier:
NCT00530777
First received: September 13, 2007
Last updated: March 22, 2012
Last verified: March 2012
Results First Received: March 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Herpes Simplex
Interventions: Drug: valacyclovir
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Valacyclovir 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
Placebo oral placebo twice daily from 34 weeks gestation to 1 year postpartum

Participant Flow:   Overall Study
    Valacyclovir     Placebo  
STARTED     74     74  
COMPLETED     67     69  
NOT COMPLETED     7     5  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Valacyclovir 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
Placebo oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Total Total of all reporting groups

Baseline Measures
    Valacyclovir     Placebo     Total  
Number of Participants  
[units: participants]
  74     74     148  
Age  
[units: participants]
     
<=18 years     3     4     7  
Between 18 and 65 years     71     70     141  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  26.2  ± 5.3     26.0  ± 4.5     26.1  ± 4.9  
Gender  
[units: participants]
     
Female     74     74     148  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Kenya     74     74     148  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation   [ Time Frame: 4 weeks ]

2.  Secondary:   Vertical HIV-1 Transmission   [ Time Frame: 1 year postpartum ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Unable to evaluate the effect of valacyclovir on MTCT or on change in HIV-1 RNA among women who were eligible for HAART. Underpowered to detect association between treatment and mother to child HIV transmission.


  More Information
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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:  
Name/Title: Dr. Carey Farquhar
Organization: University of Washington
phone: 206-543-4278
e-mail: 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.

Publications automatically indexed to this study:

Responsible Party: Carey Farquhar, University of Washington
ClinicalTrials.gov Identifier: NCT00530777     History of Changes
Other Study ID Numbers: 32462-A, 07-7306-A01, R03HD057773
Study First Received: September 13, 2007
Results First Received: March 22, 2012
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board