Trial record 4 of 4 for:    10432323 [PUBMED-IDS]

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. Identifier: NCT00530777
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : April 18, 2012
Last Update Posted : April 18, 2012
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

  Participant Flow

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
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 
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 74   74   148 
[Units: Participants]
<=18 years   3   4   7 
Between 18 and 65 years   71   70   141 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 26.2  (5.3)   26.0  (4.5)   26.1  (4.9) 
[Units: Participants]
Female   74   74   148 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
Kenya   74   74   148 

  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

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

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

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 by Identifier (NCT Number):

Responsible Party: Carey Farquhar, University of Washington Identifier: NCT00530777     History of Changes
Other Study ID Numbers: 32462-A
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: April 18, 2012