HIV Prevention Preparedness Study

This study has been completed.

First Received: October 29, 2002 Last Updated: August 7, 2008 History of Changes

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)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00048282

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:	Prospective
Official Title:	HIV Prevention Preparedness Study

Resource links provided by NLM:

MedlinePlus related topics: 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

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

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

Locations

South Africa

Durban, South Africa

Hlabisa, South Africa
Medical Research Council
Hlabisa, South Africa
R.K. Khan Hospital
Chatsworth, South Africa
Tanzania

Moshi, Tanzania
Kilimanjaro Christian Med Ctr
Moshi, Tanzania
Zambia

Chililabombwe, Zambia

Lusaka, Zambia
Chilenje Clinic, Lusaka, Sambia
Lusaka, Zambia
Kamwala Clinic
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

Additional Information:

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	HIVNET/HPTN 055
Study First Received:	October 29, 2002
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00048282 History of Changes
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

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on July 02, 2009