Cellulose Sulfate and HIV Transmission Among Women

Conditions

HIV Infection

Keywords

HIV prevention, Randomized controlled trial, Women, Sexually transmitted infections, HIV Seronegativity

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.

Guédou FA, Van Damme L, Deese J, Crucitti T, Becker M, Mirembe F, Solomon S, Alary M.

2013-05-0822 citations

10.1186/1471-2334-13-208

Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial.

Crucitti T, Fransen K, Maharaj R, Tenywa T, Massinga Loembé M, Murugavel KG, Mendonca K, Abdellati S, Beelaert G, Van Damme L.

2010-10-278 citations

10.1371/journal.pone.0013592

Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission.

Van Damme L, Govinden R, Mirembe FM, Guédou F, Solomon S, Becker ML, Pradeep BS, Krishnan AK, Alary M, Pande B, Ramjee G, Deese J, Crucitti T, Taylor D, CS Study Group.

2008-07-01325 citations

10.1056/nejmoa0707957

Interventions

DRUGCellulose Sulfate gel (6%)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Combined incidence of HIV-1 and HIV-2 in the study.	1 year

Secondary

Measure	Time frame
Time-to-first incidental gonococcal or chlamydial infection.	1 year

Countries

Benin, India, South Africa, Uganda

Outcome results

None listed