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CompletedNCT00000930Updated Nov 6, 2016

A Study of HIV in Newly Infected Individuals

An observational study in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-06.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study provides an opportunity to prospectively monitor markers of HIV infection and disease progression in cohorts suitable for HIV vaccine trials. The detection of changes in HIV phenotype and genotype, clinical progression rates, and antiretroviral resistance within study populations over time are important for planning future HIV vaccine trials.

This study consists of two parts. Part A includes HIV-infected patients who enrolled in HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been closely monitored and characterized. This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. Part B includes newly HIV-infected patients. These patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through Year 5.

02

Conditions studied

  • HIV Infections

Keywords

  • Sexual Partners
  • Drug Resistance, Microbial
  • Cohort Studies
  • Risk Factors
  • Substance Abuse, Intravenous
  • Disease Progression
  • Homosexuality, Male
  • Genotype
  • Phenotype
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Biospecimen retention
Samples with dna

Groups and cohorts

  • A

    HIV-infected individuals enrolled in HIVNET D01

  • B

    Individuals with newly acquired HIV infection

06

What researchers measure

Primary outcomes

  1. Detection of changes in HIV phenotype and genotype

    Time frame: Throughout study

  2. Clinical progression rates

    Time frame: Throughout study

  3. Antiviral resistance

    Time frame: Throughout study

07

Study locations

12 sites
  • Los Angeles County / Health Research Assoc / Drew Med Ctr
    Los Angeles, California 90033, United States
  • San Francisco Dept of Hlth / AIDS Office
    San Francisco, California 94102, United States
  • Denver Dept of Public Health / HIVNET
    Denver, Colorado 80204, United States
  • Univ of Illinois Chicago / Howard Brown Hlth Ctr
    Chicago, Illinois 60612, United States
  • Johns Hopkins Univ
    Baltimore, Maryland 21205, United States
  • Fenway Community Health Ctr / HIVNET
    Boston, Massachusetts 02115, United States
  • Bronx-Lebanon Hosp Ctr
    Bronx, New York 10453, United States
  • New York Blood Ctr
    Bronx, New York 10456, United States
  • New York Univ Med Ctr
    New York, New York 10016, United States
  • Univ of Pennsylvania / HIVNET
    Philadelphia, Pennsylvania 19104, United States
  • Miriam Hosp
    Providence, Rhode Island 02906, United States
  • Univ of Washington
    Seattle, Washington 98104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00000930
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Aug 31, 2001
Primary completion
May 2008
Completion
May 2008
Last update
Nov 6, 2016

Study contacts

Celum C
study chair
Buchbinder S
study chair
Sheppard H
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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