A Phase 3 interventional study of Cellulose Sulfate gel (6%) in HIV Infection, sponsored by CONRAD. Terminated at 5 sites in 4 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-28.
Sponsored by CONRAD · Phase 3, Interventional, and Prevention
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 1,428 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →CONRAD is the lead sponsor of 39 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The record gives a start of Jul 2005 and a completion of Mar 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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CONRAD