Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India
NCT ID: NCT00081640
Last Updated: 2009-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
120 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants in this study will be sexually active HIV uninfected women at either low or high risk for HIV infection. Male partners of these women will also be enrolled in the study. Participants will be asked to apply PRO 2000 Gel twice a day for 14 consecutive days between menses and to have vaginal intercourse with a single male partner, using study-provided male condoms, at least twice per week during the two weeks of PRO 2000 Gel use. Participants will have a screening visit, an enrollment visit, and 3 study visits during the two weeks of PRO 2000 Gel use; each visit will last about 1 hour. Study visits will include a medical history, gynecologic exam, blood and urine tests, and product acceptability questionnaires. Colposcopy will be performed three times during the study. Participants will also be asked to complete a Daily Study Record about product use and sexual activity and questionnaires about their willingness to use the product and their perceptions of the product.
Four weeks after using PRO 2000 Gel, participants will be asked to participate in a focus group to discuss product acceptability. Participants' male partners will also be asked to participate in focus groups about product use.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PRO 2000/5 Gel (P)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HIV uninfected
* Regular menstrual cycle of at least 21 days or no menstrual cycle because of long-acting progestin use
* No change in hormonal contraceptive use in the 3 months prior to study entry
* Agree to use acceptable methods of contraception during the study
* Normal Pap smear at screening or in the 3 months prior to study entry
* Sexually active with a single male sexual partner who is eligible for the study
* Agree to abstain from sexual intercourse for 48 hours before the enrollment visit
* Willing to complete Daily Study Records
* Agree to follow study directions about PRO 2000 Gel use and sexual activity during the study
* Sexually transmitted disease (STD) in the 3 months prior to study entry
* Current male partner has had an STD in the 3 months prior to study entry
* Age 18 years or older
* HIV uninfected
* No STD symptoms at study entry
* Agree to abstain from sexual intercourse for 48 hours before the enrollment visit
* Agree to have vaginal intercourse only with partner who is taking part in the study
* Agree to have vaginal intercourse at least twice a week while in the study and to use study provided male condoms
Exclusion Criteria
* Breastfeeding
* Used non-therapeutic intravenous drugs within 1 year of study
* Currently pregnant or have been pregnant in the 3 months prior to study entry
* Serious liver, kidney, or blood abnormalities
* Urinary tract infection as determined by positive urine culture
* Genital abnormality
* History of adverse reaction to anticoagulants
* History of sensitivity or allergy to latex
* Used any spermicide or spermicidally lubricated condom in the week prior to study entry
* Participated in any investigational drug trial in 30 days prior to study entry
* Used an intrauterine contraceptive device in the 3 months prior to study entry
* Abnormal Pap smear in the 3 months prior to study entry
* Gynecological surgery in the 3 months prior to study entry
* Breakthrough menstrual bleeding in the 3 months prior to study entry
* Vaginal bleeding during or following intercourse in the 3 months prior to study entry
* STD or pelvic inflammatory disease in the 3 months prior to study entry
* Current male partner has had an STD in the 3 months prior to study entry
* Current male partner has injected non-therapeutic drugs in the 3 months prior to study entry
* Signs on pelvic exam consistent with an STD other than bacterial vaginosis
* History of adverse reaction to latex
* Refuse examination or treatment for an STD or STD symptoms
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Smita N. Joshi, MBBS
Role: STUDY_CHAIR
National AIDS Research Institute (Pune, India)
Steven J. Reynolds, MD, FRCP(C)
Role: STUDY_CHAIR
Johns Hopkins University Department of Medicine
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1089/154099903322404302.
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. doi: 10.1097/00126334-200308010-00008.
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. doi: 10.1097/00002030-200302140-00005.
Trager RS. Microbicides. Raising new barriers against HIV infection. Science. 2003 Jan 3;299(5603):39. doi: 10.1126/science.299.5603.39. No abstract available.
Smita J, Soma D, Beverly B, Albert P, JoAnn K, Fang G, Missy C, Lydia ST, Anjali P, Arun R, Sanjay M, Steven J R; HIV Prevention Trial Network (HPTN) 047 Protocol Team. Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India. AIDS Res Ther. 2006 Feb 20;3:4. doi: 10.1186/1742-6405-3-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HPTN 047
Identifier Type: -
Identifier Source: org_study_id