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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00209313
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 16, 2011
Sponsor:
Collaborator:
Institute for the Development of Africa
Information provided by:
Fred Hutchinson Cancer Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV-1 and HSV-2 Coinfection HIV Infections Drug: Acyclovir Phase 2 Phase 3

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. HSV and HIV viral shedding [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. HSV suppression and HIV shedding [ Time Frame: 18 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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:

    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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Cameroon
Hospital Central
Yaounde, Cameroon
Sponsors and Collaborators
Fred Hutchinson Cancer Center
Institute for the Development of Africa
Investigators
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Principal Investigator: Francois-Xavier Mbopi-Keou, M.Sc, PhD Institute for the Development of Africa
More Information
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Responsible Party: Anna Wald, MD, MPH, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00209313    
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
Keywords provided by Fred Hutchinson Cancer Center:
HIV-1
HSV-2
Coinfection
Africa
Cameroon
Additional relevant MeSH terms:
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Coinfection
Infections
Acyclovir
Antiviral Agents
Anti-Infective Agents