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Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide

NCT00213031 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

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 PC-515 when applied vaginally at least three times weekly for 12 months. Secondary aims were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV, and other STIs.

The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women would find Carraguard acceptable. The study was not powered to determine effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 trial.

Conditions

  • HIV Infections
  • Chlamydia Trachomatis
  • Neisseria Gonorrhoeae
  • Trichomonas Vaginitis
  • Syphilis
  • Herpes Simplex

Interventions

DRUG

Carraguard (PC-515)

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Centers for Disease Control and Prevention

    collaborator FED

  • Nat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention-Surveillance & Epidemiology

    collaborator UNKNOWN

  • National Center for Infectious Diseases

    collaborator OTHER_GOV

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • Collaboration (TUC)

    collaborator UNKNOWN

  • 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 HMM van de Wijgert, Ph.D. · Population Council

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-02-29
Completion
2001-12-31

Countries

  • Thailand

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 NCT00213031 on ClinicalTrials.gov