Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
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ClinicalTrials.gov Identifier: NCT00209313 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : December 16, 2011
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Condition or disease | Intervention/treatment | Phase |
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HIV-1 and HSV-2 Coinfection HIV Infections | Drug: Acyclovir | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | March 2005 |
Actual Study Completion Date : | April 2007 |
Arm | Intervention/treatment |
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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 |
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 |
- HSV and HIV viral shedding [ Time Frame: 18 weeks ]
- HSV suppression and HIV shedding [ Time Frame: 18 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209313
Cameroon | |
Hospital Central | |
Yaounde, Cameroon |
Principal Investigator: | Francois-Xavier Mbopi-Keou, M.Sc, PhD | Institute for the Development of Africa |
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) |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | December 16, 2011 |
Last Verified: | December 2011 |
HIV-1 HSV-2 Coinfection Africa Cameroon |
Coinfection Virus Diseases Infection Parasitic Diseases |
Acyclovir Antiviral Agents Anti-Infective Agents |