Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Endo Pharmaceuticals
• Collaborators: Department for International Development, United Kingdom; Medical Research Council

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