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

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ClinicalTrials.gov Identifier: NCT00103961
Recruitment Status : Unknown
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Active, not recruiting
First Posted : February 18, 2005
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
HIV Infections Behavioral: Questionnaire

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.


Study Design

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primary HIV & Early Disease Research: American Cohort (PHAEDRA) AIEDRP
Study Start Date : January 2004
Primary Completion Date : October 2007
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
Treatment-naive and treatment-experienced HIV-infected adults
Behavioral: Questionnaire
A behavioral questionnaire will occur at Week 8


Outcome Measures

Biospecimen Retention:   Samples With DNA
Blood collection

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Allergy and Infectious Diseases (NIAID)
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:
Responsible Party: Suzane Bazner, NP, Partners Healthcare
ClinicalTrials.gov Identifier: NCT00103961     History of Changes
Other Study ID Numbers: 5U01AI052403 ( U.S. NIH Grant/Contract )
2003-P-001991
First Posted: February 18, 2005    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

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

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