A Study of HIV in Newly Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000930
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

November 2, 1999
August 31, 2001
November 7, 2016
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May 2008   (Final data collection date for primary outcome measure)
  • Detection of changes in HIV phenotype and genotype [ Time Frame: Throughout study ]
  • Clinical progression rates [ Time Frame: Throughout study ]
  • Antiviral resistance [ Time Frame: Throughout study ]
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Complete list of historical versions of study NCT00000930 on Archive Site
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A Study of HIV in Newly Infected Individuals
Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations

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.

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.

Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Specimens appropriate for clinical and laboratory assessments and necessary for evaluation of study outcome measures
Non-Probability Sample
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HIV Infections
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  • A
    HIV-infected individuals enrolled in HIVNET D01
  • B
    Individuals with newly acquired HIV infection
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2008
May 2008   (Final data collection date for primary outcome measure)

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

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:


  • Participation in a HIVNET HIV vaccine trial.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Celum C
Study Chair: Buchbinder S
Study Chair: Sheppard H
National Institute of Allergy and Infectious Diseases (NIAID)
October 2012