An Observational Study of People Who Have Recently Been Infected With HIV
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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 |
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 |
Treatment-naive and treatment-experienced HIV-infected adults
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| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| 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:
|
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 May 19, 2013