Cellulose Sulfate and HIV Transmission Among Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00153777
Recruitment Status : Terminated (IDMC recommendation)
First Posted : September 12, 2005
Last Update Posted : August 28, 2015
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Cellulose Sulfate gel (6%) Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission
Study Start Date : July 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Combined incidence of HIV-1 and HIV-2 in the study. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time-to-first incidental gonococcal or chlamydial infection. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00153777

Projet SIDA3
Cotonou, Benin
Karnataka Health Promotion Trust
Bangalore, India
YRG Care
Chennai, India
South Africa
Medical Research Council
Durban, South Africa
Makarere University - Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Principal Investigator: Lut Van Damme, MD, MSc, PhD CONRAD

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00153777     History of Changes
Other Study ID Numbers: C03-090
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by CONRAD:
HIV prevention
Randomized controlled trial
Sexually transmitted infections
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases