Status:
COMPLETED
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
Lead Sponsor:
Endo Pharmaceuticals
Collaborating Sponsors:
Medical Research Council
Department for International Development, United Kingdom
Conditions:
HIV Infections
Gonorrhea
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief 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.
Detailed Description
The HIV pandemic continues with an estimated 13,000 new infections each day, the vast majority of which are acquired through heterosexual intercourse. Although consistent and correct use of condoms by...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
9404 Patients enrolled
Trial Details
Trial ID
NCT00262106
Start Date
October 1 2005
End Date
September 1 2009
Last Update
September 10 2012
Active Locations (6)
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1
Reproductive Health and HIV Research Unit, Chris Hani Baragwanath Hospital
Bertsham, South Africa, 2013
2
Africa Centre for Health and Population Studies
Mtubatuba, South Africa, 3935
3
HIV Prevention Research Unit, Medical Research Council
Westville, South Africa, 3630
4
AMREF Lake Zone Programme
Mwanza, Tanzania