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Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 and HSV-2 Coinfection; HIV Infections

Intervention: Acyclovir (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center

Official(s) and/or principal investigator(s):
Francois-Xavier Mbopi-Keou, M.Sc, PhD, Principal Investigator, Affiliation: Institute for the Development of Africa


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: HSV and HIV viral shedding

Secondary outcome: HSV suppression and HIV shedding

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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:

1. provide independent written informed consent 2. undergo clinical evaluations 3. take study drug as directed 4. 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.

1. Known history of adverse reaction to acyclovir 2. Planned open label use of acyclovir, valacyclovir, or famciclovir 3. Positive pregnancy test 4. Active opportunistic infection

Locations and Contacts

Hospital Central, Yaounde, Cameroon
Additional Information

Starting date: March 2005
Last updated: December 14, 2011

Page last updated: August 23, 2015

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