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HIV Prevention Preparedness Study

This study has been completed.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00048282
First received: October 29, 2002
Last updated: May 13, 2010
Last verified: January 2006
History of Changes
  Purpose
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.

Condition
HIV Infections
HIV Seronegativity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: HIV Prevention Preparedness Study

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Estimated Enrollment: 1200
Detailed Description:

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
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048282

Locations
South Africa
R.K. Khan Hospital
Chatsworth, South Africa
Durban, South Africa
Medical Research Council
Hlabisa, South Africa
Hlabisa, South Africa
Tanzania
Kilimanjaro Christian Med Ctr
Moshi, Tanzania
Moshi, Tanzania
Zambia
Chililabombwe, Zambia
Chilenje Clinic, Lusaka, Sambia
Lusaka, Zambia
Kamwala Clinic
Lusaka, Zambia
Lusaka, Zambia
Sponsors and Collaborators
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)
Investigators
Study Chair: Saidi Kapiga, MD, MPH, SCD Harvard School of Public Health
Study Chair: Gita Ramjee, PhD South Africa Medical Research Council
Study Chair: Stephen Weiss, PhD University of Miami
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00048282     History of Changes
Other Study ID Numbers: HIVNET/HPTN 055 
Study First Received: October 29, 2002
Last Updated: May 13, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Incidence
HIV Seroprevalence
Vagina
Anti-Infective Agents
 Administration, Topical
Gels
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016