HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding (VIP)
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Purpose
In this study, we will determine whether treating pregnant and breastfeeding women co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2 (HSV-2) with daily valacyclovir will reduce HIV-1 levels in plasma, genital, and breast milk and will decrease the risk of mother-to-child HIV-1 transmission.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Herpes Simplex |
Drug: valacyclovir Drug: placebo |
Phase 2 |
| 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 |
| Official Title: | HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding |
- Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Vertical HIV-1 Transmission [ Time Frame: 1 year postpartum ] [ Designated as safety issue: Yes ]
| Enrollment: | 148 |
| Study Start Date: | April 2008 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
|
Drug: valacyclovir
500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
Other Name: Valtrex
|
|
Placebo Comparator: 2
oral placebo twice daily from 34 weeks gestation to 1 year postpartum
|
Drug: placebo
oral placebo twice daily from 34 weeks gestation to 1 year postpartum
|
Detailed Description:
Each year over 500,000 children become HIV-1-infected in sub-Saharan Africa after exposure to maternal virus in blood, genital secretions, and breast milk. Identifying feasible, safe, and affordable interventions that prevent mother-to-child transmission remains a priority for HIV-1 prevention research. Interventions to reduce breast milk HIV-1 transmission are lacking and most urgently needed.
We propose a randomized clinical trial to determine whether incorporating HSV-2 suppression with valacyclovir into standard prevention of mother-to-child HIV-1 transmission regimens will reduce plasma, cervical, and breast milk HIV-1 RNA levels and risk of transmission among HIV-1-infected and HSV-2-seropositive women. We plan to enroll a total of 148 HIV-1 and HSV-2 co-infected pregnant women with CD4>200 cells/μl who seek antenatal care prior to 32 weeks gestation at a clinic in Nairobi, Kenya. Women will be randomized to receive either valacyclovir suppressive therapy or placebo at 34 weeks gestation and mother-infant pairs will be followed for 12 months postpartum. Follow-up visits will be scheduled at 38 weeks gestation; birth; 2, 6, 10 and 14 weeks; and 6, 9, and 12 months postpartum. Maternal blood, genital, and breast milk specimens obtained at follow-up visits will be used to determine the effect of valacyclovir suppressive therapy on plasma and breast milk HIV-1 RNA levels. Infant filter paper specimens for HIV-1 DNA assays will be collected at birth; 2, 6, 10 and 14 weeks; and 6, 9, and 12 months in order to compare the proportion of infants acquiring HIV-1 by 12 months in the two study arms and determine the timing of HIV-1 infection. In addition, we will monitor maternal and infant renal function in preparation for a larger randomized clinical trial in Africa. The results of this study will help guide the design of a multi-site clinical trial with adequate power to determine the effect of HSV-2 suppression on vertical transmission of HIV-1 infection.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 seropositive
- HSV-2 seropositive
- Plans to deliver in Nairobi
- Resides and plans to remain in Nairobi for 12 months postpartum
- 18 years of age or older
- CD4 count>250 cells/μl
Exclusion Criteria:
- indication for highly active antiretroviral therapy (e.g., WHO stage III or IV)
- hypersensitivity to valacyclovir or acyclovir
Contacts and Locations| Kenya | |
| Mathare North City Clinic | |
| Nairobi, Kenya | |
| Principal Investigator: | Carey Farquhar, MD, MPH | University of Washington |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Carey Farquhar, Associate Professor, 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 |
Keywords provided by University of Washington:
|
Disease Transmission, Vertical valacyclovir Randomized Controlled Trials HIV |
herpes Herpesvirus 2, Human HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013