Cellulose Sulfate and HIV Transmission Among Women

This study has been terminated.
(IDMC recommendation)
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by:
CONRAD
ClinicalTrials.gov Identifier:
NCT00153777
First received: September 8, 2005
Last updated: May 7, 2007
Last verified: May 2007

September 8, 2005
May 7, 2007
July 2005
Not Provided
Combined incidence of HIV-1 and HIV-2 in the study. [ Time Frame: 1 year ]
Combined incidence of HIV-1 and HIV-2 in the study.
Complete list of historical versions of study NCT00153777 on ClinicalTrials.gov Archive Site
Time-to-first incidental gonococcal or chlamydial infection. [ Time Frame: 1 year ]
Time-to-first incidental gonococcal or chlamydial infection.
Not Provided
Not Provided
 
Cellulose Sulfate and HIV Transmission Among Women
Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infection
Drug: Cellulose Sulfate gel (6%)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1428
March 2007
Not Provided

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Benin,   India,   South Africa,   Uganda
 
NCT00153777
C03-090
Yes
Not Provided
CONRAD
  • United States Agency for International Development (USAID)
  • Bill and Melinda Gates Foundation
Principal Investigator: Lut Van Damme, MD, MSc, PhD CONRAD
CONRAD
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP