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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00086372




Registration number
NCT00086372
Ethics application status
Date submitted
30/06/2004
Date registered
1/07/2004
Date last updated
29/10/2012

Titles & IDs
Public title
Long-term Follow-up of HIV Infected Patients Identified During Early Infection
Scientific title
Acute HIV Infection and Early Disease Research Program (AIEDRP) CORE01 Database
Secondary ID [1] 0 0
ACTG A5228
Secondary ID [2] 0 0
AIEDRP CORE01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria

- Documented acute or recent HIV infection

- Willing to allow study investigators access to and use of participant's medical
information from other AIEDRP clinical trials

- Parent or guardian willing to provide informed consent, if applicable

- If enrolled at an AIDS Clinical Trial Group (ACTG) site, must also be participating in
one of the following clinical trials: AIN501/ACTG A5216, AIN503/ACTG A5217, or
AIN504/ACTG A5218
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- More than 7 days of antiretroviral therapy prior to study entry without adequate
documentation of pretreatment viral load and CD4 count. Individuals who have failed
postexposure prophylaxis with antiretroviral treatment are not excluded from
enrollment.

- Any factor that, in the opinion of the study official, may interfere with study
participation

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
Accrual to date
Final
157
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
University of New South Wales - Darlinghurst
Recruitment hospital [2] 0 0
Prahran Market Clinic - St. Kilda
Recruitment hospital [3] 0 0
The Centre Clinic - St. Kilda
Recruitment hospital [4] 0 0
Carlton Clinic - Carlton VID
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3182 - St. Kilda
Recruitment postcode(s) [3] 0 0
3053 - Carlton VID
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
Brazil
State/province [11] 0 0
Bahia
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Zimbabwe
State/province [14] 0 0
Harare

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Acute Infection and Early Disease Research Program
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00086372
Trial related presentations / publications
Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. doi: 10.1086/420745. Epub 2004 Apr 30.
Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540. Erratum In: J Clin Invest. 2006 Dec;116(12):3292.
Public notes

Contacts
Principal investigator
Name 0 0
Martin Markowitz, MD
Address 0 0
Aaron Diamond AIDS Research Center, Rockefeller University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries