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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

February 17, 2005
September 25, 2008
January 2004
October 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00103961 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Observational Study of People Who Have Recently Been Infected With HIV
Primary HIV & Early Disease Research: American Cohort (PHAEDRA) AIEDRP

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood collection

Probability Sample

Treatment-naive and treatment-experienced HIV-infected adults

HIV Infections
Behavioral: Questionnaire
A behavioral questionnaire will occur at Week 8
1
Treatment-naive and treatment-experienced HIV-infected adults
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
December 2014
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented acute or recent HIV infection as defined in the study protocol
  • Willing to be followed longitudinally by this study
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103961
5U01AI052403, 2003-P-001991, 5U01-AI052403
Not Provided
Suzane Bazner, NP, Partners Healthcare
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Eric Rosenberg, MD Partners Healthcare, Massachusetts General Hospital
Principal Investigator: Bruce D. Walker, MD Partners Healthcare, Massachusetts General Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP