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HIV InfectionsNCT00000915

An HIV Vaccine Preparedness Study

A study testing Vaccine preparedness in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Vaccine preparedness
How many people
4,892 participants
Where
8 sitesUnited States
Study dates
Start not givento not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 27Show fewer
  • 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.
  • Willing to participate in a couples-based condom promotion intervention.
  • Willing and able to attend each scheduled intervention/follow-up study visit.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Johns Hopkins Univ

    Baltimore, Maryland, 21205

  • Univ of Illinois Hosp at Chicago

    Chicago, Illinois, 60612

  • Los Angeles County / Health Research Assoc / Drew Med Ctr

    Los Angeles, California, 90059

  • New York Univ Med Ctr

    New York, New York, 10016

  • Univ of Pennsylvania / HIVNET

    Philadelphia, Pennsylvania, 19104

  • Miriam Hosp

    Providence, Rhode Island, 02906

  • Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10456

  • New York Blood Ctr

    The Bronx, New York, 10456

Other trials in United States

About this study

Official title: HIV Vaccine Preparedness Study

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.

Read the detailed description

Vaccine preparedness studies are necessary in order to prepare for launching preventive HIV vaccine efficacy trials. It is important to gather information on the risk of HIV infection among recruited populations, the extent and stability of HIV risk behaviors in these populations, and the risk of HIV infection associated with risk behaviors. This vaccine preparedness study is designed to expand the capacity of the HIVNET to implement HIV prevention trials, increase the diversity of its participant population, and further target populations at highest risk of HIV infection.

Participants complete a total of 6 scheduled study visits: 2 at baseline, 2 at follow-up 6 months later, and 2 at follow-up 12 months after enrollment. Participant risk behaviors and knowledge of and attitudes toward HIV vaccine and other HIV prevention trials are assessed at each time point. HIV infection status is tested by standard HIV ELISA and Western blot at follow-up, as well as at participant request throughout the study. Participants are instructed to recognize and report suspected primary HIV infection based on symptoms or high-risk exposures. HIV pre-test, risk reduction, and post-test counseling is provided in accordance with CDC standards of practice. Participants who become infected with HIV during the study are counseled and referred for medical and psychosocial services.

Conditions
HIV Infections
Being tested
Vaccine preparedness
Keywords
AIDS Vaccines, Incidence, Knowledge, Attitudes, Practice, Risk-Taking
Medical subject headings
HIV Infections, Behavior, Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaccine preparednessBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Enrolment
4,892 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000915
Sponsor's protocol ID
HIVNET D01
Status last verified
Mar 1999
First submitted
2 Nov 1999
Last updated
24 Jun 2005
Results posted
No

Publications

  • Woody GE, VanEtten-Lee ML, McKirnan D, Donnell D, Metzger D, Seage G 3rd, Gross M; HIVNET VPS 001 Protocol Team. Substance use among men who have sex with men: comparison with a national household survey. J Acquir Immune Defic Syndr. 2001 May 1;27(1):86-90. doi: 10.1097/00126334-200105010-00015.

    PubMed 11404525

Questions about this trial

What is this clinical trial studying?

A study testing Vaccine preparedness in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000915, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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