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Clinical Trials

MainTitle

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 (Responsible Party)
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier
NCT00209313

First received: September 13, 2005
Last updated: December 14, 2011
Last Verified: December 2011
History of Changes
Purpose

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
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

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures

  • HSV and HIV viral shedding [ Time Frame: 18 weeks ]
Secondary Outcome Measures:
  • HSV suppression and HIV shedding [ Time Frame: 18 weeks ]

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: April 2007

Arms Assigned Interventions
Other: 1
Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo
Drug: Acyclovir

Acyclovir 800 mg twice daily or placebo

Other: 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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

    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

    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

    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  

    Keywords provided by Fred Hutchinson Cancer Research Center:

    HIV-1
    HSV-2
    Coinfection
    Africa
    Cameroon

    Additional relevant MeSH terms:
    HIV Infections
    Coinfection
    Acyclovir

    ClinicalTrials.gov processed this data on October 16, 2017
    This information is provided by ClinicalTrials.gov.