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
  Purpose

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 Intervention Phase
HIV Infection
Drug: Cellulose Sulfate gel (6%)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission

Resource links provided by NLM:


Further study details as provided by CONRAD:

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

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

Enrollment: 1428
Study Start Date: July 2005
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153777

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

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00153777     History of Changes
Other Study ID Numbers: C03-090
Study First Received: September 8, 2005
Last Updated: May 7, 2007
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
Uganda: National Council for Science and Technology
Benin: Ministere de la Sante
India: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014