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

NCT00209313 | Completed Phase 2

• 2 other identifiers: IR File 5687AI 30731 (Project 1)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1 and HSV-2 Coinfection; HIV Infections

Keywords

HIV-1; HSV-2; Coinfection; Africa; Cameroon

Outcome Measures

Primary Outcomes (1)

• HSV and HIV viral shedding

  18 weeks

Secondary Outcomes (1)

• HSV suppression and HIV shedding

  18 weeks

Study Arms (2)

1

OTHER

Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo

Drug: Acyclovir

2

OTHER

8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily

Drug: Acyclovir

Interventions

Acyclovir DRUG

Acyclovir 800 mg twice daily or placebo

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• provide independent written informed consent
• undergo clinical evaluations
• take study drug as directed
• 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.

You may not qualify if:

• Women who meet any of the following criteria are not eligible for this study.
• Known history of adverse reaction to acyclovir
• Planned open label use of acyclovir, valacyclovir, or famciclovir
• Positive pregnancy test
• Active opportunistic infection

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Institute for the Development of Africa: collaborator

Study Sites (1)

Hospital Central

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

HIV Infections; Coinfection

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

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

  Institute for the Development of Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2005
• Study Completion: April 1, 2007
• Last Updated: December 16, 2011

Record last verified: 2011-12

Locations

CA (1)