An HIV Vaccine Preparedness Study

Completed · Not applicable

Conditions studied: HIV Infections

In brief

The purpose of this study is to estimate the rate at which a certain population becomes infected with HIV. The individuals examined in this study are people who are expected to take part in future studies of HIV vaccines and nonvaccine HIV prevention studies. This study also examines the chances of becoming HIV-positive based on certain risk factors under conditions that are similar to the conditions that would exist in HIV vaccine and non-HIV prevention studies. Before studying the effectiveness of a potential HIV vaccine, it is important to learn about the range of HIV risk behaviors in the potential participants of these studies. The probability of HIV infection associated with these risk behaviors should also be examined. This study is designed to increase the ability of HIVNET to put into place HIV prevention trials, to increase the diversity of trial participants, and to target populations at highest risk for HIV infection.

Key facts

Study ID

NCT00000915

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

4892

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants meet the following criteria:
• HIV-seronegative.
• Available for 6 months of the study. (Note:
• Participants who plan to move from one study location to another are eligible.)
• Willing and able to provide information for locator purposes.
• Report one or more of the following risk behaviors:
• For men:
• Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.
• Anal intercourse (receptive or insertive) with one or more other men in the last year.
• For women:
• Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.
• Having a current male sex partner who is infected with HIV.
• Having a current male sex partner who has injected drugs in the last 5 years.
• Having 5 or more male sex partners in the last year.
• Diagnosis of syphilis, chlamydia, gonorrhea, first episode herpes, pelvic inflammatory disease, and/or trichomoniasis in the last year.
• Exchange of sex for money or drugs in the last year.
• Use of crack cocaine in the last 12 months.
• See General Inclusion Criteria for required risk behaviors.
• Volunteers must be:
• HIV-positive through HIVNET testing or HIV-seronegative by EIA.
• Presently in a sexual relationship of at least 6 months duration with the intention to remain with this partner for the duration of the study.
• Willing to identify and recruit this sexual partner to which he/she has disclosed or will disclose HIV serostatus.
• Willing to receive counseling and HIV testing (HIV-seronegative partners only).
• Willing to agree to be interviewed with their partner and individually.
• Willing to continue engaging in sex with their partner.

You may not qualify if…

• Co-existing Condition:
• Persons with the following symptoms or conditions are excluded:
• An obvious psychological or psychiatric disorder that would preclude provision of informed consent or otherwise contraindicate study participation.
• Any condition which in the opinion of the principal investigator would interfere with achieving the study objectives.
• Men at risk through anal intercourse only are excluded if they:
• Currently have a single HIV-seronegative partner with whom they have been in a mutually monogamous relationship for at least 2 years.
• Men and women at risk through injection only are excluded if they:
• Have been participating in any methadone drug treatment program for at least the last 6 months.
• Currently obtain over 50 percent of needles/syringes for injection of drugs from a needle exchange program.
• NOTE:
• Meeting the following extremely high injection risk criteria overrides the exclusion criteria for injection risk as outlined above:
• Using a needle or syringe after one or more known HIV-positive persons 2 or more times in the past 3 months.
• Using a needle or syringe after persons of unknown HIV status in the past 3 months provided the following two conditions are true:
• (1) report using a needle or syringe after someone else 2 or more different times in the past 3 months and (2) report using a needle or syringe after 3 or more different persons in the past 3 months. (This second criterion could be met in 3 episodes of injection with a single injection partner, if the participant used a needle or syringe after a different person each time. Alternatively, the criterion could be met in a single episode of injection, if the participant used a needle or syringe after 3 or more persons had used a single set of works.)
• Concurrent Medication:
• Excluded:
• Enrollment in an HIV vaccine trial, unless approval is obtained from the Data Management Committee Project Officer.
• Risk Behavior:
• See General Exclusion Criteria for excluded risk behaviors.

Where it is running

• Los Angeles County / Health Research Assoc / Drew Med Ctr — Los Angeles, California, United States
• Univ of Illinois Hosp at Chicago — Chicago, Illinois, United States
• Johns Hopkins Univ — Baltimore, Maryland, United States
• New York Univ Med Ctr — New York, New York, United States
• Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
• New York Blood Ctr — The Bronx, New York, United States
• Univ of Pennsylvania / HIVNET — Philadelphia, Pennsylvania, United States
• Miriam Hosp — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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