A Study of HIV in Newly Infected Individuals

HIV Infections Clinical Trial

Official title:

Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000930
• Other study ID #: HIVNET 019
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: November 4, 2016
• Est. completion date: May 2008

Study information

• Verified date: October 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Locations

Country	Name	City	State
United States	Johns Hopkins Univ	Baltimore	Maryland
United States	Fenway Community Health Ctr / HIVNET	Boston	Massachusetts
United States	Bronx-Lebanon Hosp Ctr	Bronx	New York
United States	New York Blood Ctr	Bronx	New York
United States	Univ of Illinois Chicago / Howard Brown Hlth Ctr	Chicago	Illinois
United States	Denver Dept of Public Health / HIVNET	Denver	Colorado
United States	Los Angeles County / Health Research Assoc / Drew Med Ctr	Los Angeles	California
United States	New York Univ Med Ctr	New York	New York
United States	Univ of Pennsylvania / HIVNET	Philadelphia	Pennsylvania
United States	Miriam Hosp	Providence	Rhode Island
United States	San Francisco Dept of Hlth / AIDS Office	San Francisco	California
United States	Univ of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of changes in HIV phenotype and genotype		Throughout study	No
Primary	Clinical progression rates		Throughout study	No
Primary	Antiviral resistance		Throughout study	No