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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00103961
First received: February 17, 2005
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primary HIV & Early Disease Research: American Cohort (PHAEDRA) AIEDRP

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Blood collection


Enrollment: 500
Study Start Date: January 2004
Estimated Study Completion Date: December 2014
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Treatment-naive and treatment-experienced HIV-infected adults
Behavioral: Questionnaire
A behavioral questionnaire will occur at Week 8

Detailed Description:

This study will collect data on the immunological and virologic responses that occur early in the course of HIV infection in treated and untreated HIV infected adults to identify host immunological, virological, and therapeutic factors that influence disease progression. This study will also monitor changing patterns in the transmission of drug-resistant viral strains and evaluate ongoing behavioral risk factors associated with HIV infection.

Participants in this study will be followed for up to 10 years. During the first year of participation, study visits will occur approximately every 4 weeks for the first 12 weeks, then every 12 weeks thereafter, with a minimum of 8 study visits during the first year. Participants will be asked to complete a behavioral questionnaire at Week 8. After the first year of participation, there will be 4 visits per year. Blood collection and vital sign measurement will occur at each study visit.

Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Treatment-naive and treatment-experienced HIV-infected adults

Criteria

Inclusion Criteria:

  • Documented acute or recent HIV infection as defined in the study protocol
  • Willing to be followed longitudinally by this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103961

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Eric Rosenberg, MD Partners Healthcare, Massachusetts General Hospital
Principal Investigator: Bruce D. Walker, MD Partners Healthcare, Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Suzane Bazner, NP, Partners Healthcare
ClinicalTrials.gov Identifier: NCT00103961     History of Changes
Other Study ID Numbers: 5U01AI052403, 2003-P-001991, 5U01-AI052403
Study First Received: February 17, 2005
Last Updated: September 25, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acute Infection
HIV
AIDS
Acute HIV
Early HIV

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014