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

NCT ID: NCT00209313

Last Updated: 2011-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV-1 and HSV-2 Coinfection HIV Infections

Keywords

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HIV-1 HSV-2 Coinfection Africa Cameroon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo

Group Type OTHER

Acyclovir

Intervention Type DRUG

Acyclovir 800 mg twice daily or placebo

2

8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily

Group Type OTHER

Acyclovir

Intervention Type DRUG

Acyclovir 800 mg twice daily or placebo

Interventions

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Acyclovir

Acyclovir 800 mg twice daily or placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institute for the Development of Africa

UNKNOWN

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Fred Hutchinson Cancer Research Center

Principal Investigators

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Francois-Xavier Mbopi-Keou, M.Sc, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for the Development of Africa

Locations

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Hospital Central

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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AI 30731 (Project 1)

Identifier Type: -

Identifier Source: secondary_id

IR File 5687

Identifier Type: -

Identifier Source: org_study_id