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NCT00153777 Clinical Trial

Cellulose Sulfate and HIV Transmission Among Women

HIV Infection Clinical Trial

Official title:
Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00153777
Other study ID # C03-090
Secondary ID
Status Terminated
Phase Phase 3
First received September 8, 2005
Last updated August 27, 2015
Start date July 2005
Est. completion date March 2007

Study information
Verified date August 2015
Source CONRAD
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilUganda: National Council for Science and TechnologyBenin: Ministere de la SanteIndia: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1428
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Cellulose Sulfate gel (6%)

Locations
Country Name City State
Benin Projet SIDA3 Cotonou
India Karnataka Health Promotion Trust Bangalore
India YRG Care Chennai
South Africa Medical Research Council Durban
Uganda Makarere University - Mulago Hospital Kampala

Sponsors (3)
Lead Sponsor Collaborator
CONRAD Bill and Melinda Gates Foundation, United States Agency for International Development (USAID)

Countries where clinical trial is conducted

Benin,  India,  South Africa,  Uganda, 

References & Publications (7)

Anderson RA, Feathergill KA, Diao XH, Cooper MD, Kirkpatrick R, Herold BC, Doncel GF, Chany CJ, Waller DP, Rencher WF, Zaneveld LJ. Preclinical evaluation of sodium cellulose sulfate (Ushercell) as a contraceptive antimicrobial agent. J Androl. 2002 May-Jun;23(3):426-38. — View Citation

Crucitti T, Jespers V, Van Damme L, Van Dyck E, Buvé A. Vaginal microbicides can interfere with nucleic acid amplification tests used for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infection. Diagn Microbiol Infect Dis. 2007 Jan;57(1):97-9. Epub 2006 Jul 21. — View Citation

El-Sadr WM, Mayer KH, Maslankowski L, Hoesley C, Justman J, Gai F, Mauck C, Absalon J, Morrow K, Mâsse B, Soto-Torres L, Kwiecien A. Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women. AIDS. 2006 May 12;20(8):1109-16. — View Citation

Malonza IM, Mirembe F, Nakabiito C, Odusoga LO, Osinupebi OA, Hazari K, Chitlange S, Ali MM, Callahan M, Van Damme L. Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel. AIDS. 2005 Dec 2;19(18):2157-63. — View Citation

Mauck C, Frezieres R, Walsh T, Robergeau K, Callahan M. Cellulose sulfate: tolerance and acceptability of penile application. Contraception. 2001 Dec;64(6):377-81. — View Citation

Mauck C, Weiner DH, Ballagh S, Creinin M, Archer DF, Schwartz J, Pymar H, Lai JJ, Callahan M. Single and multiple exposure tolerance study of cellulose sulfate gel: a Phase I safety and colposcopy study. Contraception. 2001 Dec;64(6):383-91. — View Citation

Schwartz JL, Mauck C, Lai JJ, Creinin MD, Brache V, Ballagh SA, Weiner DH, Hillier SL, Fichorova RN, Callahan M. Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study. Contraception. 2006 Aug;74(2):133-40. Epub 2006 May 2. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Combined incidence of HIV-1 and HIV-2 in the study. 1 year
Secondary Time-to-first incidental gonococcal or chlamydial infection. 1 year
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