Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission

Summary

The primary aims of the study were to assess the safety and acceptability of Carraguard ™ (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV.

The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; 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 efficacy trial.

Conditions

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

Interventions

DRUG

Carraguard (PC-515)

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• FHI 360

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Medical Research Council, South Africa

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• University of Limpopo

  collaborator OTHER

• United States Agency for International Development (USAID)

  collaborator FED

• Population Council

  lead OTHER

Principal Investigators

• Charlotte E. Ellertson, MPA, Ph.D. · Population Council

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1999-10-31

Completion

2002-01-31

Countries

• South Africa

Study Locations