NCT00000930

Brief Summary

The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients. Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 7, 2016

Status Verified

October 1, 2012

First QC Date

November 2, 1999

Last Update Submit

November 4, 2016

Conditions

HIV Infections

Keywords

Sexual PartnersDrug Resistance, MicrobialCohort StudiesRisk FactorsSubstance Abuse, IntravenousDisease ProgressionHomosexuality, MaleGenotypePhenotype

Outcome Measures

Primary Outcomes (3)

  • Detection of changes in HIV phenotype and genotype

    Throughout study

  • Clinical progression rates

    Throughout study

  • Antiviral resistance

    Throughout study

Study Arms (2)

A

HIV-infected individuals enrolled in HIVNET D01

B

Individuals with newly acquired HIV infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • Patients must have:
  • HIV infection, as documented by enrollment in HIVNET D01.1 (Part A patients) or by standard HIV serological tests or demonstrated HIV infection on virologic assay (Part B patients).
  • Part A only:
  • Previous enrollment in infected-participants cohort of HIVNET D01.
  • Part B only:
  • Initial HIV-seronegativity on an HIVNET protocol (other than an HIV vaccine protocol) and testing positive for HIV at a subsequent clinic visit.
  • Confirmation of HIV infection and documentation of HIV negative antibody test within 8 months of first positive test.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions are excluded:
  • An obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study.
  • Prior Medication:
  • Excluded:
  • Participation in a HIVNET HIV vaccine trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Los Angeles County / Health Research Assoc / Drew Med Ctr

Los Angeles, California, 90033, United States

Location

San Francisco Dept of Hlth / AIDS Office

San Francisco, California, 94102, United States

Location

Denver Dept of Public Health / HIVNET

Denver, Colorado, 80204, United States

Location

Univ of Illinois Chicago / Howard Brown Hlth Ctr

Chicago, Illinois, 60612, United States

Location

Johns Hopkins Univ

Baltimore, Maryland, 21205, United States

Location

Fenway Community Health Ctr / HIVNET

Boston, Massachusetts, 02115, United States

Location

New York Univ Med Ctr

New York, New York, 10016, United States

Location

Bronx-Lebanon Hosp Ctr

The Bronx, New York, 10453, United States

Location

New York Blood Ctr

The Bronx, New York, 10456, United States

Location

Univ of Pennsylvania / HIVNET

Philadelphia, Pennsylvania, 19104, United States

Location

Miriam Hosp

Providence, Rhode Island, 02906, United States

Location

Univ of Washington

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specimens appropriate for clinical and laboratory assessments and necessary for evaluation of study outcome measures

MeSH Terms

Conditions

HIV InfectionsSubstance Abuse, IntravenousDisease ProgressionHomosexuality, Male

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHomosexualitySexualitySexual BehaviorBehavior

Study Officials

  • Celum C

    STUDY CHAIR

  • Buchbinder S

    STUDY CHAIR

  • Sheppard H

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 7, 2016

Record last verified: 2012-10

Locations

US(12)