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

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center Institute for the Development of Africa
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00209313

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 II Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HSV suppression and HIV shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2005
Estimated Study Completion Date:	September 2008

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years and older
Genders 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

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

No publications provided

Responsible Party:	Fred Hutchinson Cancer Research Center ( Anna Wald, MD, MPH )
Study ID Numbers:	IR File 5687, AI 30731 (Project 1)
Study First Received:	September 13, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00209313 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:

HIV-1
HSV-2
Coinfection
Africa
Cameroon

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Acyclovir
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Antiviral Agents
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
Acyclovir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009