NCT00209313

CompletedPhase 2/3

Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfe...

Fred Hutchinson Cancer Center Source

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Other study identifiers

Sponsor study identifier

IR File 5687

Secondary identifiers

AI 30731 (Project 1)

Study Type

interventional

Estimated enrollment

40

Locations

1 country

Sites

1

Timeline

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

April 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 40 participants
Study completion date: April 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)
Study Completion
April 2007
Actual (reported)

Last Updated: December 16, 2011
Status Verified: December 2011
Last Update Submitted: December 14, 2011

Conditions

HIV Infections HIV-1 and HSV-2 Coinfection

Keywords

HIV-1HSV-2CoinfectionAfricaCameroon

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

AcyclovirDrug

Acyclovir 800 mg twice daily or placebo

12

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years old and above
Documented HIV-seropositive

Sponsors & Collaborators

Institute for the Development of Africa
Type not reportedcollaborator
Fred Hutchinson Cancer Center
Otherlead

Study Sites (1)

Hospital Central

Yaoundé, Cameroon

MeSH Terms

Conditions

HIV InfectionsCoinfection

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital Diseases

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 3
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 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

April 2007

Actual (reported)

NCT00076232

A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

Phase 3Completed

NCT02349828

Antiviral Prophylaxis in a Burn Population

Phase 2/3Withdrawn

NCT01729767

Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease

Phase 2/3Unknown

NCT00002026

Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)

Not ApplicableCompleted

NCT00362596

A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand

Phase 4Completed

NCT00119106

Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand

Phase 2/3Completed

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

Contact the study team to confirm eligibility.

Immunologic Deficiency Syndromes

Immune System Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Last Updated

December 16, 2011

Record last verified: 2011-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00209313
Data provider: ClinicalTrials.gov
Source updated: 2011-12-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:56 UTC

Locations

CM(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations