Clinical trial NCT00153777: Cellulose Sulfate and HIV Transmission Among Women
Official title: Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV Infection
Keywords: HIV prevention
Randomized controlled trial
Women
Sexually transmitted infections
HIV Seronegativity
Lead sponsor: CONRAD
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Bill and Melinda Gates Foundation
First posted: 2005-09-12
Enrollment: 1428
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Combined incidence of HIV-1 and HIV-2 in the study.
timeFrame: 1 year
Secondary outcomes:
measure: Time-to-first incidental gonococcal or chlamydial infection.
timeFrame: 1 year
Other outcomes:
Locations:
city: Cotonou
country: Benin
facility: Projet SIDA3
city: Bangalore
country: India
facility: Karnataka Health Promotion Trust
city: Chennai
country: India
facility: YRG Care
city: Durban
country: South Africa
facility: Medical Research Council
city: Kampala
country: Uganda
facility: Makarere University - Mulago Hospital
Study officials:
affiliation: CONRAD
name: Lut Van Damme, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crucitti T, Jespers V, Van Damme L, Van Dyck E, Buve 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. doi: 10.1016/j.diagmicrobio.2006.05.010. Epub 2006 Jul 21.
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. doi: 10.1016/j.contraception.2006.02.008. Epub 2006 May 2.
citation: El-Sadr WM, Mayer KH, Maslankowski L, Hoesley C, Justman J, Gai F, Mauck C, Absalon J, Morrow K, Masse 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. doi: 10.1097/01.aids.0000226950.72223.5f.
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. doi: 10.1097/01.aids.0000194797.59046.8f.
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. doi: 10.1016/s0010-7824(01)00271-2.
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. doi: 10.1016/s0010-7824(01)00270-0.
citation: 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.
citation: Guedou FA, Van Damme L, Deese J, Crucitti T, Becker M, Mirembe F, Solomon S, Alary M. Behavioural and medical predictors of bacterial vaginosis recurrence among female sex workers: longitudinal analysis from a randomized controlled trial. BMC Infect Dis. 2013 May 8;13:208. doi: 10.1186/1471-2334-13-208.
citation: Crucitti T, Fransen K, Maharaj R, Tenywa T, Massinga Loembe M, Murugavel KG, Mendonca K, Abdellati S, Beelaert G, Van Damme L. Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial. PLoS One. 2010 Oct 27;5(10):e13592. doi: 10.1371/journal.pone.0013592.
citation: Van Damme L, Govinden R, Mirembe FM, Guedou F, Solomon S, Becker ML, Pradeep BS, Krishnan AK, Alary M, Pande B, Ramjee G, Deese J, Crucitti T, Taylor D; CS Study Group. Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission. N Engl J Med. 2008 Jul 31;359(5):463-72. doi: 10.1056/NEJMoa0707957.