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| Sponsors and Collaborators: |
University of Washington Royalty Research Fund - University of Washington Puget Sound Partners for Global Health National Institutes of Health (NIH) |
|---|---|
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00530777 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding |
| Estimated Enrollment: | 148 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
|
|
2: Placebo Comparator
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
|
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:
Exclusion Criteria:
Contacts and Locations| Contact: Alison L Drake, MPH | 206-579-9211 | adrake2@u.washington.edu |
| Contact: Carey Farquhar, MD, MPH | 206-543-4278 | cfarq@u.washington.edu |
| Kenya | |
| Mathare North City Clinic | Recruiting |
| Nairobi, Kenya | |
| Contact: James Kiarie, MMed, MPH 254-20-2714159 jkiarie@swiftkenya.com | |
| Principal Investigator: Carey Farquhar, MD, PMH | |
| Principal Investigator: James Kiarie, MMed, MPH | |
| Principal Investigator: Barbra Richardson, PhD | |
| Principal Investigator: Alison L Drake, MPH | |
| Principal Investigator: | Carey Farquhar, MD, MPH | University of Washington |
More Information
| Responsible Party: | University of Washington ( Dr. Carey Farquhar, Assistant Professor ) |
| Study ID Numbers: | 32462-A, 07-7306-A01 |
| Study First Received: | September 13, 2007 |
| Last Updated: | April 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00530777 History of Changes |
| Health Authority: | United States: Institutional Review Board; Kenya: Institutional Review Board |
|
Disease Transmission, Vertical valacyclovir Randomized Controlled Trials HIV |
herpes Herpesvirus 2, Human HIV Seronegativity |
|
Herpes Simplex Sexually Transmitted Diseases, Viral Skin Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Valacyclovir Skin Diseases, Infectious HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
|
Herpes Simplex Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Skin Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes |
Herpesviridae Infections Valacyclovir Skin Diseases, Viral Virus Diseases Skin Diseases, Infectious HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections |
