A Study of HIV in Newly Infected Individuals

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000930
First received: November 2, 1999
Last updated: October 29, 2012
Last verified: October 2012

November 2, 1999
October 29, 2012
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  • Detection of changes in HIV phenotype and genotype [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Clinical progression rates [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Antiviral resistance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00000930 on ClinicalTrials.gov 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
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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:

Excluded:

  • Participation in a HIVNET HIV vaccine trial.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000930
HIVNET 019
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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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP