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HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

NCT00465205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-08-22

No results posted yet for this study

Summary

Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission.

The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation.

This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.

Conditions

  • HIV Infections
  • Herpes Simplex
  • Sexually Transmitted Diseases

Interventions

DRUG

Valacyclovir

500mg oral twice daily

DRUG

Matching Placebo

500 mg oral twice daily

Sponsors & Collaborators

Principal Investigators

  • Connie Celum, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2005-12-31
Completion
2007-12-31

Countries

  • Peru

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00465205 on ClinicalTrials.gov