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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
Sponsor:
Collaborator:
Institute for the Development of Africa
Information provided by:
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date December 16, 2011
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
HSV and HIV viral shedding [ Time Frame: 18 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
HSV and HIV viral shedding in 18 weeks
Change History Complete list of historical versions of study NCT00209313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
HSV suppression and HIV shedding [ Time Frame: 18 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
HSV suppression and HIV shedding in 18 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV-1 and HSV-2 Coinfection
  • HIV Infections
Intervention  ICMJE Drug: Acyclovir
Acyclovir 800 mg twice daily or placebo
Study Arms  ICMJE
  • 1
    Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo
    Intervention: Drug: Acyclovir
  • 2
    8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily
    Intervention: Drug: Acyclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 13, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cameroon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209313
Other Study ID Numbers  ICMJE IR File 5687
AI 30731 (Project 1)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Wald, MD, MPH, Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE Institute for the Development of Africa
Investigators  ICMJE
Principal Investigator: Francois-Xavier Mbopi-Keou, M.Sc, PhD Institute for the Development of Africa
PRS Account Fred Hutchinson Cancer Research Center
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP