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Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand

NCT00213057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-08-14

No results posted yet for this study

Summary

The primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted.

The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.

Conditions

  • HIV Infections
  • Chlamydia Trachomatis
  • Nesseria Gonorrhea
  • Trichomonas Vaginitis
  • Syphilis

Interventions

DRUG

Carraguard (PC-515)

Sponsors & Collaborators

  • Centers for Disease Control and Prevention

    collaborator FED

  • 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

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Population Council

    lead OTHER

Principal Investigators

  • Kelly Blanchard, MSc · Population Council

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-06-30
Completion
2002-06-30

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 NCT00213057 on ClinicalTrials.gov