Cellulose Sulfate and HIV Transmission Among Women
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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 |
- Combined incidence of HIV-1 and HIV-2 in the study. [ Time Frame: 1 year ]
- Time-to-first incidental gonococcal or chlamydial infection. [ Time Frame: 1 year ]
| Enrollment: | 1428 |
| Study Start Date: | July 2005 |
| Study Completion Date: | March 2007 |
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 |
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| 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 | |
| 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:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013