A Study of HIV in Newly Infected Individuals

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000930
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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.

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2012-10
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of changes in HIV phenotype and genotype	Throughout study
Antiviral resistance	Throughout study
Clinical progression rates	Throughout study

Trial Locations

Locations (12)

San Francisco Dept of Hlth / AIDS Office; 🇺🇸 San Francisco, California, United States

Univ of Illinois Chicago / Howard Brown Hlth Ctr; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Univ; 🇺🇸 Baltimore, Maryland, United States

Fenway Community Health Ctr / HIVNET; 🇺🇸 Boston, Massachusetts, United States

New York Univ Med Ctr; 🇺🇸 New York, New York, United States

Los Angeles County / Health Research Assoc / Drew Med Ctr; 🇺🇸 Los Angeles, California, United States

Denver Dept of Public Health / HIVNET; 🇺🇸 Denver, Colorado, United States

Univ of Pennsylvania / HIVNET; 🇺🇸 Philadelphia, Pennsylvania, United States

Miriam Hosp; 🇺🇸 Providence, Rhode Island, United States

Univ of Washington; 🇺🇸 Seattle, Washington, United States

Bronx-Lebanon Hosp Ctr; 🇺🇸 Bronx, New York, United States

New York Blood Ctr; 🇺🇸 Bronx, New York, United States