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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

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 Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
A; HIV-infected individuals enrolled in HIVNET D01
B; Individuals with newly acquired HIV infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection of changes in HIV phenotype and genotype	Throughout study
Clinical progression rates	Throughout study
Antiviral resistance	Throughout study

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Celum C; Study Chair: Buchbinder S; Study Chair: Sheppard H

Study record dates

Study Major Dates

• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Genotype; Risk Factors; Disease Progression; Phenotype; Cohort Studies; Sexual Partners; Substance Abuse, Intravenous; Drug Resistance, Microbial; Homosexuality, Male
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: HIVNET 019