Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Institute for the Development of Africa
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00209313
First received: September 13, 2005
Last updated: December 14, 2011
Last verified: December 2011
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Purpose
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 |
|---|---|---|
|
HIV-1 and HSV-2 Coinfection HIV Infections |
Drug: Acyclovir |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Fred Hutchinson Cancer Research Center:
Primary Outcome Measures:
- HSV and HIV viral shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HSV suppression and HIV shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2005 |
| Study Completion Date: | April 2007 |
| Arms | Assigned Interventions |
|---|---|
|
1
Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo
|
Drug: Acyclovir
Acyclovir 800 mg twice daily or placebo
|
|
2
8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily
|
Drug: Acyclovir
Acyclovir 800 mg twice daily or placebo
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years old and above
- Documented HIV-seropositive
- HSV-2 seropositive as determined by Focus EIA
- Not intending to move out of the area for the duration of study participation
-
Willing and able to:
- provide independent written informed consent
- undergo clinical evaluations
- take study drug as directed
- adhere to follow-up schedule
- Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea, chlamydia, syphilis) are treated within two weeks if study enrollment and random assignment.
Exclusion Criteria:
-
Women who meet any of the following criteria are not eligible for this study.
- Known history of adverse reaction to acyclovir
- Planned open label use of acyclovir, valacyclovir, or famciclovir
- Positive pregnancy test
- Active opportunistic infection
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209313
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209313
Locations
| Cameroon | |
| Hospital Central | |
| Yaounde, Cameroon | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Institute for the Development of Africa
Investigators
| Principal Investigator: | Francois-Xavier Mbopi-Keou, M.Sc, PhD | Institute for the Development of Africa |
More Information
| Responsible Party: | Anna Wald, MD, MPH, Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00209313 History of Changes |
| Other Study ID Numbers: | IR File 5687 AI 30731 (Project 1) |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
HIV-1 HSV-2 Coinfection Africa Cameroon |
Additional relevant MeSH terms:
|
HIV Infections Coinfection Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Infection Parasitic Diseases Acyclovir Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 27, 2016