Cellulose Sulfate and HIV Transmission Among Women

Phase 3

Terminated

• Conditions: HIV Infection

• Registration Number: NCT00153777
• Lead Sponsor: CONRAD

Brief Summary

The purpose of the study is to determine the effect of cellulose sulfate on the transmission of HIV to women via vaginal intercourse. The secondary objectives are the effect on the transmission of gonorrhea and chlamydia via the same route.

The study hypothesis is that there will be no effect.

Detailed Description

Despite the availability of an effective HIV prevention method, i.e. the condom, the epidemic continues growing. There is thus an urgent need for additional HIV prevention methods. One of the possibilities is the use of microbicides, i.e. chemical products which may be used in the vagina or rectum with the potential to prevent HIV infection.

Cellulose sulfate is an HIV entry inhibitor with an in vitro effect on N. gonorrhoeae (NG) and C. trachomatis (CT) and other sexually transmitted organisms.

The study assess its effect on the vaginal transmission of HIV, NG and CT among women at high risk of heterosexual STI infection (defined as having had more than two partners in the last three months and an average of three sexual acts per week).

The study is randomized, triple-blinded, placebo controlled.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2007-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-27
• Last Update Posted: 2015-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1428

Inclusion Criteria

• at least 18 years old
• an average of at least three vaginal sex acts per week, at least three different partners in the last three months, expecting to continue this behavior
• HIV negative
• willing and able to comply with the protocol

Exclusion Criteria

• pregnancy
• allergy to latex or spermicides
• intravenous drug user

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Combined incidence of HIV-1 and HIV-2 in the study.	1 year

Secondary Outcome Measures

Name	Time	Method
Time-to-first incidental gonococcal or chlamydial infection.	1 year

Trial Locations

Locations (5)

Makarere University - Mulago Hospital; 🇺🇬 Kampala, Uganda

Projet SIDA3; 🇧🇯 Cotonou, Benin

Karnataka Health Promotion Trust; 🇮🇳 Bangalore, India

YRG Care; 🇮🇳 Chennai, India

Medical Research Council; 🇿🇦 Durban, South Africa