Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
HIV Infections, Gonorrhea, Chlamydial Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Administration, intravaginal, Anti-infective agents, Double blind method, Drug evaluation, Female, Gels, HIV infections/prevention and control, Microbicide, Naphthalenesulfonates/administration and dosage, Polymers/administration and dosage, Sexual behavior, Vaginal creams, foams and jellies, HIV Seronegativity, Genital Herpes Infections
Eligibility Criteria
Inclusion Criteria: Women aged 16 years and above at enrolment in Masaka and Mwanza, or aged 18 years and above at enrolment in the South African and Zambian sites Likely to be sexually active at entry and during follow-up Willing to undergo HIV testing at screening and approximately 12 weekly intervals, and additionally, if required, to determine HIV status HIV negative at screening according to the local HIV testing algorithm Willing to receive the HIV result before randomization Willing to use study gel as instructed Willing to undergo regular speculum examinations and genital infection screens Willing to have regular urine pregnancy tests Willing to receive health education about condoms Willing and able to give informed consent Exclusion Criteria: Unable or unwilling to provide a reliable method of contact for the field team Likely to move permanently out of the area within the next year Likely to have sex more than 14 times a week on a regular basis during the course of follow-up Using spermicides regularly Pregnant or within 6 weeks postpartum at enrollment Has Grade 3 clinical or laboratory abnormalities which are considered by the clinician or the Trial Management Group to make enrollment inadvisable Requires referral for assessment of a clinically suspicious cervical lesion Treatment to the cervix, or to the womb through the cervix, within 30 days of enrolment Known latex allergy Participating, or has participated within 30 days of enrolment, in a clinical trial of an unlicensed product, microbicide, barrier method, or any other intervention likely to impact on the outcome of this trial Considered unlikely to be able to comply with the protocol
Sites / Locations
- Reproductive Health and HIV Research Unit, Chris Hani Baragwanath Hospital
- Africa Centre for Health and Population Studies
- HIV Prevention Research Unit, Medical Research Council
- AMREF Lake Zone Programme
- MRC Programme on AIDS in Uganda, Uganda Virus Research Institute
- MDP Zambia, Nakambala Sugar Estate
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
PRO 2000/5 Gel 0.5%
placebo
PRO 2000/5 Gel 0.5%