HIV Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
Pro 2000/5 (P) 0.5% and 2% gels, Placebo gel
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Sexually active 2. HIV-negative healthy women 3. Not pregnant
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to provide a reliable method of contact for the field team 2. Likely to move permanently out of the area within the next year 3. Likely to have sex more than 14 times a week on a regular basis during the course of follow-up 4. Using spermicides regularly 5. Pregnant or within 6 weeks postpartum at enrolment 6. Has grade 3 clinical or laboratory abnormalities which are considered by the clinician or the Trial Management Group to make enrolment inadvisable 7. Requiring referral for assessment of a clinically suspicious cervical lesion 8. Treatment to the cervix, or to the womb through the cervix, within 30 days of enrolment 9. Known latex allergy 10. Participating, or having 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 11. Considered unlikely to be able to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acquisition of HIV infection before or at the 9 month time point, confirmed by a Central Reference Laboratory, in participants confirmed to be HIV negative at enrolment 2. Grade 3 (severe) or 4 (life-threatening) clinical events noted through systematically solicited questions, or laboratory adverse events confirmed on examination or repeat testing respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acquisition of HIV infection before or at the 6 and 12 month time points, confirmed by a Central Reference Laboratory, in participants confirmed to be HIV negative at enrolment 2. Acquisition of herpes simplex virus type 2 (HSV-2) in women uninfected at enrolment 3. The point prevalence of Neisseria gonorrhoeae (NG) or Chlamydia trachomatis (CT) after 24 weeks of follow-up, determined by a positive nucleic acid amplification assay 4. All systematically solicited genital adverse events 5. All clinical and laboratory adverse events | — |
Countries
South Africa, Tanzania, Uganda, United Kingdom, Zambia
Outcome results
None listed