HIV Infections Clinical Trial
Official title:
An International Multi-centre, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 0.5% and 2% PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
Verified date | September 2012 |
Source | Endo Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9404 |
Est. completion date | September 2009 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | Reproductive Health and HIV Research Unit, Chris Hani Baragwanath Hospital | Bertsham | |
South Africa | Africa Centre for Health and Population Studies | Mtubatuba | |
South Africa | HIV Prevention Research Unit, Medical Research Council | Westville | |
Tanzania | AMREF Lake Zone Programme | Mwanza | |
Uganda | MRC Programme on AIDS in Uganda, Uganda Virus Research Institute | Entebbe | |
Zambia | MDP Zambia, Nakambala Sugar Estate | Mazabuka |
Lead Sponsor | Collaborator |
---|---|
Endo Pharmaceuticals | Department for International Development, United Kingdom, Medical Research Council |
South Africa, Tanzania, Uganda, Zambia,
Mayer KH, Karim SA, Kelly C, Maslankowski L, Rees H, Profy AT, Day J, Welch J, Rosenberg Z; HIV Prevention Trials Network (HPTN) 020 Protocol Team. Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women. AIDS. 2003 Feb 14;17(3):321-9. — View Citation
Morrow K, Rosen R, Richter L, Emans A, Forbes A, Day J, Morar N, Maslankowski L, Profy AT, Kelly C, Abdool Karim SS, Mayer KH. The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial. J Womens Health (Larchmt). 2003 Sep;12(7):655-66. — View Citation
Tabet SR, Callahan MM, Mauck CK, Gai F, Coletti AS, Profy AT, Moench TR, Soto-Torres LE, Poindexter III AN, Frezieres RG, Walsh TL, Kelly CW, Richardson BA, Van Damme L, Celum CL. Safety and acceptability of penile application of 2 candidate topical microbicides: BufferGel and PRO 2000 Gel: 3 randomized trials in healthy low-risk men and HIV-positive men. J Acquir Immune Defic Syndr. 2003 Aug 1;33(4):476-83. Erratum in: J Acquir Immune Defic Syndr. 2003 Sep 1;34(1):118. — View Citation
Van Damme L, Wright A, Depraetere K, Rosenstein I, Vandersmissen V, Poulter L, McKinlay M, Van Dyck E, Weber J, Profy A, Laga M, Kitchen V. A phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women. Sex Transm Infect. 2000 Apr;76(2):126-30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acquisition of HIV infection before or at the 12 month time point, confirmed in a central laboratory, in participants confirmed to be HIV negative at enrollment | 12 months | Yes | |
Primary | Grade 3 (severe) or 4 (life-threatening) clinical or laboratory adverse event confirmed on examination or repeat testing, respectively | 12 months | Yes | |
Secondary | Acquisition of HIV infection before or at the 6, 9, or beyond 12 month time points, confirmed in a central laboratory, in participants confirmed to be HIV negative at enrollment | 6, 9 and 12 months | Yes | |
Secondary | HSV-2 incidence rates by the 9 month time point in participants uninfected at enrollment. Although prevalence rates are high, 75% - 85% in some sites, data from feasibility studies indicate that incidence rates are also likely to be high | 9 months | Yes | |
Secondary | HSV-2 incidence rates by the 12 month time point in participants uninfected at enrolment. Although prevalence rates are high, 75% - 85% in some sites, data from feasibility studies indicate that incidence rates are also likely to be high | 12 months | Yes | |
Secondary | Cross-sectional prevalence of Neisseria gonorrhoeae at 24 weeks, determined by a positive nucleic acid amplification assay | 24 weeks/6 months | Yes | |
Secondary | Cross-sectional prevalence of Chlamydia trachomatis at 24 weeks, determined by a positive nucleic acid amplification assay | 24 wks/6 months | Yes |
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