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

NCT ID: NCT00362596

Last Updated: 2006-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-08-31

Brief Summary

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Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission. Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes Simplex Virus Type-2 (HSV-2) in Thailand.

Detailed Description

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65 women ages 18-49 years old with HIV-1 and HSV-2 co-infection are being recruited from general medicine clinics, family planning clinics, postnatal clinics, community based organizations and community outreach in Chiang Rai, Thailand.

Our study objectives are:

* To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
* To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
* To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
* To evaluate the association of genital symptoms and HIV or HSV genital shedding.
* To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.

Conditions

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HIV Herpes

Keywords

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Acyclovir HIV HSV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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acyclovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* participants will be HIV and HSV-2 seropositive

Exclusion Criteria

* pregnancy, CD4 count \<200, on ART
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Thailand

OTHER_GOV

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Eileen F. Dunne, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Sara Whitehead, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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TUC

Chiang Rai, Changwat Chiang Rai, Thailand

Site Status

Countries

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Thailand

References

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Dunne EF, Whitehead S, Sternberg M, Thepamnuay S, Leelawiwat W, McNicholl JM, Sumanapun S, Tappero JW, Siriprapasiri T, Markowitz L. Suppressive acyclovir therapy reduces HIV cervicovaginal shedding in HIV- and HSV-2-infected women, Chiang Rai, Thailand. J Acquir Immune Defic Syndr. 2008 Sep 1;49(1):77-83. doi: 10.1097/QAI.0b013e3181831832.

Reference Type DERIVED
PMID: 18667923 (View on PubMed)

Other Identifiers

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CDC-NCHSTP-4178

Identifier Type: -

Identifier Source: org_study_id