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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Female
HIV-1 and HSV-2 Coinfection, HIV Infections

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

HSV and HIV viral shedding

Outcome Time Frame:

18 weeks

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute for the Development of Africa

Authority:

United States: Institutional Review Board

Study ID:

IR File 5687

NCT ID:

NCT00209313

Start Date:

March 2005

Completion Date:

April 2007

Related Keywords:

  • HIV-1 and HSV-2 Coinfection
  • HIV Infections
  • HIV-1
  • HSV-2
  • Coinfection
  • Africa
  • Cameroon
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

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