Long Term Follow-Up of HIV Infected Patients Who Have Previously Participated in HIV Clinical Trials

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00183287
First received: September 13, 2005
Last updated: April 25, 2012
Last verified: April 2012

September 13, 2005
April 25, 2012
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Complete list of historical versions of study NCT00183287 on ClinicalTrials.gov Archive Site
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Long Term Follow-Up of HIV Infected Patients Who Have Previously Participated in HIV Clinical Trials
Clinical, Virologic, and Immunologic Evaluation and Monitoring of Patients With Known or Suspected HIV Infection

The purpose of this study is to monitor the progression of HIV infection and HIV-related disease processes in patients who have previously participated in HIV clinical trials.

Since 1982, the National Institute of Allergy and Infectious Diseases (NIAID) has been conducting numerous clinical trials on patients infected with HIV-1. Unfortunately, once clinical studies have closed or participants have reached a study endpoint, no additional follow-up data are collected regarding progression of HIV infection and development of HIV-related complications in these study participants. This study will collect long-term data for participants of previous NIAID-sponsored clinical trials to study HIV-related disease processes and complications, benefits and toxicities of investigational medications and vaccines, and medical management of participants with known or suspected HIV infection.

Study visits will occur every 6 months. A physical exam, blood collection, and medical history will occur at all visits. Depending on the need of participants, additional laboratory and diagnostic tests will be performed, and standard medical care will be provided.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood collection

Non-Probability Sample

HIV-infected individuals who have previously participated in NIAID-funded HIV clinical trials

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
March 2003
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Inclusion Criteria:

  • HIV infected
  • Previously participated in a NIAID-funded clinical trial studying HIV disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00183287
IRP 020, 11754
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: JoAnn M. Mican, MD Laboratory of Immunoregulation (LIR), NIAID
National Institute of Allergy and Infectious Diseases (NIAID)
April 2012

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