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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Comprehensive International Program of Research on AIDS |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00371592 |
The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time.
Condition | Intervention | Phase |
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HIV Infections Herpesvirus 2, Human |
Drug: Acyclovir Drug: Acyclovir placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Suppression of Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load and Mucosal Shedding in HIV-1, Herpes Simplex Virus, Type 2 (HSV-2) Co-Infected Women |
Estimated Enrollment: | 50 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive acyclovir for 24 weeks
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Drug: Acyclovir
800 mg tablet taken orally twice daily
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2: Placebo Comparator
Participants will receive acyclovir placebo for 24 weeks
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Drug: Acyclovir placebo
800 mg placebo tablet taken orally twice daily
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Women coinfected with HIV and HSV-2 experience more genital herpes outbreaks than women infected only with HSV-2. Frequent or recurrent herpes outbreaks in women infected with HIV can lead to an increase in both HIV plasma viral load and cervical shedding of HIV. Some preliminary clinical studies have shown that acyclovir treatment for the management of HSV-2 infection can help lower HIV viral load in patients coinfected with both HIV and HSV-2.
Supplementing highly active antiretroviral therapy (HAART) with HSV-2 treatment in patients coinfected with both HIV and HSV-2 may help strengthen the effects of HAART by more effectively lowering plasma and genital HIV viral load. This study will determine whether HSV-2 treatment with acyclovir is effective in controlling HIV plasma viral load and cervical shedding of HIV in women starting on HAART as per Peruvian guidelines.
This study will last 24 weeks. Participants will be randomly assigned into one of two groups. Group 1 participants will receive twice-daily 800 mg of acyclovir for 24 weeks. Group 2 participants will receive twice-daily placebo for 24 weeks. Both groups will receive HAART from the Peruvian Ministry of Health. There will be 15 visits during this study. Medical history; a physical exam; blood collection; family planning counseling; and cervical, vaginal, and vulvar swab collection will begin prior to study entry and will occur at all study visits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Peru, Lima | |
Asociacion Civil Impacta Salud y Educacion (IMPACTA) - San Miguel | Recruiting |
San Miguel, Lima, Peru, 14 | |
Contact: Shyla Sanchez 511-1-562-1600 ssnchez@impactaperu.org |
Study Chair: | Aldo Lucchetti, MD | Asociación Civil Impacta Salud y Educación, Lima, Peru |
Study Chair: | Connie Celum, MD, MPH | University of Washington, Harborview Medical Center |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | CIPRA PE 003, CIPRA Peru Project 1 |
Study First Received: | September 1, 2006 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00371592 History of Changes |
Health Authority: | United States: Federal Government |
Treatment Naive |
Herpes Simplex Sexually Transmitted Diseases, Viral Skin Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Skin Diseases, Infectious Acyclovir 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 Skin Diseases, Viral Virus Diseases Skin Diseases, Infectious Acyclovir HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections |