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HIV Prevention Preparedness Study Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about HIV Prevention Preparedness Study conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. HIV Prevention Preparedness Study Clinical research trials and HIV Prevention Preparedness Study health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like HIV Prevention Preparedness Study. HIV Prevention Preparedness Study Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a HIV Prevention Preparedness Study clinical trial. Human subjects often get the best healthcare available for their HIV Prevention Preparedness Study condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > HIV Prevention Preparedness Study  HIV Prevention Preparedness Study
HIV Prevention Preparedness Study
For Condition: HIV Seronegativity,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD),National Institute of Mental Health (NIMH),National Institute on Drug Abuse (NIDA)
Synopsis: 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.
Details: This study is designed to prepare for the implementation of a second study, HPTN 035: A Phase II/III Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women. HPTN 035 requires an average HIV seroincidence rate of 5-6 percent among enrolled participants. The primary objective of the present study is to estimate the rates of HIV seroincidence among women targeted for inclusion in HPTN 035. Women will be enrolled in this study for 6 to 12 months. Study visits will take place monthly. At each visit, participants will complete a medical/menstrual history and undergo pregnancy testing. Each quarter, participants will undergo a structured interview about sexual practices and will receive HIV and STD tests, education, and counseling. Participants will also undergo a pelvic exam with wet mount testing for bacterial vaginosis, candidiasis, and trichomoniasis. Colposcopic evaluations will be performed at selected sites. Pap smears will be performed at sites with the capacity and expertise to prepare and interpret the smears and provide appropriate follow-up care to participants with abnormal results.
Eligibility:
Study Type: Observational, Screening, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: 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.
Total Enrollment: 1200
Location and Contact Information:
Overall Study Official:
SaidiKapiga, Study Chair, Harvard School of Public Health
Medical Research Council *Recruiting*
Hlabisa, ,
South Africa
Recruiting Nozizwe Dladla 270-358-38115
Kilimanjaro Christian Med Ctr *Recruiting*
Moshi, ,
Tanzania
Recruiting Lori Miller
R.K. Khan Hospital *Recruiting*
Chatsworth, ,
South Africa
Recruiting Roshini Govinden 273-120-34702
Additional Information:
Study ID Numbers: HIVNET/HPTN 055;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048282
Other Hiv Seronegativity Studies:
1. Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, including Long-term Non-progressors
2. Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
3. A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
4. HIV Symptom Management Program for African American Mothers
5. The Effectiveness of Human Antibodies in Influencing an AIDS-Like Disease in Monkeys
Related Studies:
Other HIV Seronegativity Clinical Trials
Other Clinical Trials
Other Moshi Clinical Trials
HIV Prevention Preparedness Study
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