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A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women

NCT00213044 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-08-15

No results posted yet for this study

Summary

Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited from general medical clinics, family planning clinics, groups/organizations working with persons living with AIDS to assess product safety, effect on genital tract HIV shedding, and product acceptability with vaginal use of Carraguard gel among HIV-infected women. Women had to be abstinent or in a seroconcordant relationship with only one partner for the study period.

Conditions

  • HIV Infections

Interventions

DRUG

Carraguard (PC-515)

Sponsors & Collaborators

  • Centers for Disease Control and Prevention

    collaborator FED

  • National Center for HIV STD and TB Prevention

    collaborator UNKNOWN

  • National Center for Infectious Diseases

    collaborator OTHER_GOV

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • Chiang Rai Public Health Office

    collaborator OTHER_GOV

  • Chiang Rai District Health Office

    collaborator OTHER_GOV

  • Chiang Rai Municipal Health Office

    collaborator OTHER_GOV

  • Chiang Rai Hospital

    collaborator OTHER

  • Population Council

    lead OTHER

Principal Investigators

  • Janneke van de Wijgert, PhD · Population Council

  • Catherine McClean · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Completion
2004-06-30

Countries

  • Thailand

Study Locations

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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 NCT00213044 on ClinicalTrials.gov