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A Study of Nonoxynol-9 (N-9) and HIV Infection Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Study of Nonoxynol-9 (N-9) and HIV Infection conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study of Nonoxynol-9 (N-9) and HIV Infection Clinical research trials and A Study of Nonoxynol-9 (N-9) and HIV Infection medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Study of Nonoxynol-9 (N-9) and HIV Infection. A Study of Nonoxynol-9 (N-9) and HIV Infection Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Study of Nonoxynol-9 (N-9) and HIV Infection clinical trial. Subjects typically recieve the finest healthcare available for their A Study of Nonoxynol-9 (N-9) and HIV Infection condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.

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A Study of Nonoxynol-9 (N-9) and HIV Infection



A Study of Nonoxynol-9 (N-9) and HIV Infection

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if nonoxynol-9 (N-9) gel used in the vagina can prevent the spread of HIV. Most of the people with HIV in the world today live in southern Africa. Because this population is not likely to use condoms, an HIV-prevention method that women can control is needed. N-9 used in the vagina may help prevent the spread of HIV and other sexually transmitted diseases.
Details: Intravaginal application of N-9 may help protect women from HIV and other STD infection. Low rates of condom use in sub-Saharan African populations, which constitute the majority of HIV infections, dictate the need for prophylactic methods women can control. This trial will be conducted in Zimbabwe and Malawi. The Phase III trial is preceded by a 2-week safety and acceptability pilot study to determine the extent of genital irritation caused by N-9 and the placebo. Following the pilot study and prior to screening for enrollment in the Phase III trial, potential volunteers will participate in a 2-month behavioral counseling program that will encourage the use of condoms. Only participants who decide they cannot or will not be consistent condom users are enrolled in the main study. Study participants are given N-9 gel or placebo to use each time they have vaginal sexual intercourse for 18 to 36 months. Participants have a follow-up evaluation once a month; a pelvic exam and blood tests are performed every third month.
Eligibility:
Study Type:
  Interventional, Prevention, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria Volunteers may be eligible if they: - Are HIV-negative. - Are sexually active and expect to have vaginal intercourse at least twice a week during the study. - Are willing to keep a diary of their sexual behavior and N-9 use. - Are willing to have regular clinic visits including pelvic exams. - Are at least 18 years old. - Are female. Exclusion Criteria Volunteers will not be eligible if they: - Have had a child or an abortion in the past 42 days. - Are allergic to latex or N-9. - Have genital sores. - Have syphilis, chlamydia, gonorrhea, or trichomoniasis. - Are enrolled in another study for a product like N-9. - Expect to use another vaginal product other than N-9 during the study. - Are pregnant.
Total Enrollment: 4400

Location and Contact Information:

Overall Study Official:
TahaE.Taha,  Study Chair, 

Julia Welch
Research Triangle Park,  North Carolina,  27709
United States
 


Additional Information:
Study ID Numbers:
  HIVNET 016; 
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000926

Other Hiv Infections Studies:
1. An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

2. Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy

3. A Study of MDL 28,574A in HIV-Infected Patients

4. Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient

5. To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI).

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