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BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women 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 BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women Clinical research trials and BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women 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 BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women. BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women 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 BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women clinical trial. Human subjects often get the best healthcare available for their BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women 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 > "B" Clinical Trials Conditions > BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women  BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
For Condition: HIV Infections,HIV Seronegativity
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD),National Institute on Drug Abuse (NIDA),National Institute of Mental Health (NIMH)
Synopsis: The majority of HIV infected people worldwide became infected with the virus through heterosexual contact. BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women from becoming infected with HIV during sexual intercourse with an HIV infected partner. This study will test the safety and effectiveness of these gels.
Details: Accessible, usable, and effective vaginal microbicides could significantly decrease the spread of HIV. Vaginal microbicides could be used with condoms to prevent HIV infection; they could also be used in situations in which an individual is unable to negotiate condom use. Vaginal microbicides are potentially bi-directional, preventing both male-to-female and female-to-male HIV transmission. This study will evaluate the safety and effectiveness of two vaginal microbicides, BufferGel and PRO 2000/5, in preventing the transmission of HIV. The study will also evaluate the effectiveness of these gels in preventing other common sexually transmitted infections (STIs). BufferGel is a buffering agent designed to maintain normal vaginal acidity in the presence of ejaculate. Studies have shown that HIV is inactivated below a pH of 4 to 5.8. Carbopol 974, the major nonaqueous component of BufferGel, is commonly used as a gelling or tableting agent and has a well-documented safety record. BufferGel has proven safe and well tolerated in Phase I studies. PRO 2000/5 inhibits viral entry into susceptible cells. PRO 2000/5 has also been evaluated in Phase I studies and was found to be safe and well tolerated. Participants in this study will be randomly assigned to one of four study arms: BufferGel, PRO 2000/5, placebo gel, or no gel. All participants will receive HIV risk reduction counseling, condoms, and diagnosis and treatment of sexually transmitted diseases. Participants in the three gel arms will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of the product (BufferGel, PRO 2000/5, or placebo gel) intravaginally up to 60 minutes before each vaginal intercourse while in the study. Participants will have a screening study visit and then monthly visits. Monthly study visits may take place at a clinic, the participant’s home, or other community site. Monthly visits will include a medical interview, pregnancy testing, HIV and STI risk reduction counseling, and distribution of study supplies (condoms and gel-filled applicators). Four times a year, participants will be seen in the clinic for a more structured medical interview, pelvic exam, and HIV testing. The first 800 participants will have pelvic exams and HIV testing during their first 3 monthly visits. Participants will be enrolled for approximately 12 to 30 months, depending on when they enter the study.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Single Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - HIV uninfected - Had sexual intercourse at least once in the three months prior to study entry - Of legal age to provide independent informed consent per local regulations and guidelines - Able to provide adequate address information to study officials for purposes of follow up Exclusion Criteria: - History of adverse reaction to latex - Nonmedical injection drug use in the 12 months prior to study entry - Vaginal intercourse more than an average of two times per day in the 2 weeks prior to study entry - Plan to become pregnant in the next 30 months - Plan to travel away from the study site for more than 3 consecutive months in the next 30 months - Plan to relocate away from the study site in the next 30 months - Participation in another clinical trial of a vaginal gel - Pregnant within 42 days of study entry - Condition that, in the opinion of study officials, may interfere with the study
Total Enrollment: 3100
Location and Contact Information:
Overall Study Official:
SalimKarim, Study Chair, University of Natal
Additional Information:
Study ID Numbers: HPTN 035;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074425
Other Hiv Infections Studies:
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2. Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
3. A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
4. A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
5. Safety and Immune Response Study of the Vaccine ALVAC vCP1452 Alone or in Combination with AIDSVAX B/B
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BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
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