An Observational Study of People Who Have Recently Been Infected With HIV

NCT00103961 | Completed

• 2 other identifiers: 5U01AI0524032003-P-001991
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP). The purpose of this study is to collect data on the immunological and virologic responses that occur early in the course of HIV infection in treatment-naive and treatment-experienced HIV infected adults. Study hypothesis: This study will examine the immunological responses that occur early in the course of HIV infection in treated and untreated individuals. The long-term follow-up of these subjects will help identify host immunological and genetic factors along with therapeutic strategies associated with control of viremia and delayed disease progression. In addition, this cohort will provide the recruiting mechanism to support future trials of therapy to restore immune function. Furthermore, this cohort will provide a population suitable to monitoring changing patterns in the transmission of drug resistant viral strains while also evaluating ongoing behavioral risk factors associated with HIV transmission.

Conditions

HIV Infections

Keywords

Acute Infection; HIV; AIDS; Acute HIV; Early HIV

Study Arms (1)

1

Treatment-naive and treatment-experienced HIV-infected adults

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

A behavioral questionnaire will occur at Week 8

1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Treatment-naive and treatment-experienced HIV-infected adults

You may qualify if:

• Documented acute or recent HIV infection as defined in the study protocol
• Willing to be followed longitudinally by this study

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

• Click here for more information on AIEDRP CORE01

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric Rosenberg, MD

  Partners Healthcare, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Bruce D. Walker, MD

  Partners Healthcare, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 17, 2005
• First Posted: February 18, 2005
• Study Start: January 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2014
• Last Updated: November 28, 2018

Record last verified: 2008-09

Locations

US (2)