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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center Institute for the Development of Africa |
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Information provided by: | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00209313 |
The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.
Condition | Intervention | Phase |
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HIV-1 and HSV-2 Coinfection HIV Infections |
Drug: Acyclovir |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Acyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons in Cameroon |
Estimated Enrollment: | 40 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | September 2008 |
Arms | Assigned Interventions |
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1
Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo
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Drug: Acyclovir
Acyclovir 800 mg twice daily or placebo
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2
8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily
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Drug: Acyclovir
Acyclovir 800 mg twice daily or placebo
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The main objective is to assess the reduction in genital HIV-1 shedding associated with daily acyclovir for suppression of HSV-2 reactivation.
All patients will be treated with the usual antibiotic treatment for any sexually transmitted infections that are diagnosed during the study. In addition, half will receive acyclovir for 8 weeks , whilst the other half will receive a placebo for 8 weeks. The study medication will reverse in the second 8 weeks of the study. The patients will attend the clinic 3 times per week during the first and the last 8 weeks of the study and once every week during the washout period in the middle of the study - for a total of 18 weeks per participant. At each visit genital and oral samples will be collected. A blood sample will also be collected. For women participants, pregnancy test will be performed. The clinic will provide both pre- and post-HIV test counseling.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Willing and able to:
Exclusion Criteria:
Women who meet any of the following criteria are not eligible for this study.
Cameroon | |
Hospital Central | |
Yaounde, Cameroon |
Principal Investigator: | Francois-Xavier Mbopi-Keou, M.Sc, PhD | Institute for the Development of Africa |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Anna Wald, MD, MPH ) |
Study ID Numbers: | IR File 5687, AI 30731 (Project 1) |
Study First Received: | September 13, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00209313 |
Health Authority: | United States: Institutional Review Board |
HIV-1 HSV-2 Coinfection Africa Cameroon |
Virus Diseases Sexually Transmitted Diseases, Viral Acyclovir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses |
Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |