HIV Infections Clinical Trial
Official title:
HIV Prevention Preparedness Study
NCT number | NCT00048282 |
Other study ID # | HIVNET/HPTN 055 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | October 29, 2002 |
Last updated | May 13, 2010 |
The purpose of this study is to provide researchers with information that will help them prepare for a future study to test the efficacy of two anti-HIV vaginal gels. This study will also estimate how likely people living in certain areas are to become infected with HIV and other infections passed during sex.
Status | Completed |
Enrollment | 1200 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion criteria: - Sexually active (defined as having had vaginal intercourse at least once in the 3 months prior to screening). - HIV-uninfected at screening. - Able and willing to provide adequate locator information for study retention purposes. Exclusion criteria: - History of adverse reaction to latex. - Non-therapeutic injection drug use in the 12 months prior to screening. - Vaginal intercourse more than an average of 2 times per day in the 2 weeks prior to screening. - Plans to travel away from the study site for more than 3 consecutive months in the next 12 months. - Plans to relocate away from the study site in the next 12 months. - Pregnancy or plans to become pregnant in the next 12 months. - Pregnancy within 42 days prior to enrollment. - Enrollment in any other study of a vaginally-applied product. - Clinically apparent pelvic exam finding involving deep epithelial disruption. - Diagnosis with a current STD and/or other reproductive tract infection requiring treatment. - Conditions that would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
South Africa | R.K. Khan Hospital | Chatsworth | |
South Africa | Medical Research Council | Hlabisa | |
Tanzania | Kilimanjaro Christian Med Ctr | Moshi | |
Zambia | Chilenje Clinic, Lusaka, Sambia | Lusaka | |
Zambia | Kamwala Clinic | Lusaka |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA) |
South Africa, Tanzania, Zambia,
Kapiga S, Kelly C, Weiss S, Daley T, Peterson L, Leburg C, Ramjee G. Risk factors for incidence of sexually transmitted infections among women in South Africa, Tanzania, and Zambia: results from HPTN 055 study. Sex Transm Dis. 2009 Apr;36(4):199-206. doi: — View Citation
Ramjee G, Kapiga S, Weiss S, Peterson L, Leburg C, Kelly C, Masse B; HPTN 055 Study Team. The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials: experience from the HPTN 055 study. J Acquir Immune Defic — View Citation
Schreiber CA, Sammel M, Hillier SL, Barnhart KT. A little bit pregnant: modeling how the accurate detection of pregnancy can improve HIV prevention trials. Am J Epidemiol. 2009 Feb 15;169(4):515-21. doi: 10.1093/aje/kwn345. Epub 2008 Dec 18. — View Citation
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