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

This study is not yet open for participant recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), September 2005

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00183287
  Purpose

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.


Condition
HIV Infections

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Clinical, Virologic, and Immunologic Evaluation and Monitoring of Patients With Known or Suspected HIV Infection

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood collection


Estimated Enrollment:   150
Study Start Date:   September 2009
Estimated Primary Completion Date:   September 2010 (Final data collection date for primary outcome measure)

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

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


Criteria

Inclusion Criteria:

  • HIV infected
  • Previously participated in a NIAID-funded clinical trial studying HIV disease
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183287

Sponsors and Collaborators

Investigators
Principal Investigator:     JoAnn M. Mican, MD     Laboratory of Immunoregulation (LIR), NIAID    
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Responsible Party:   DAIDS ( Rona Siskind )
Study ID Numbers:   IRP 020
First Received:   September 13, 2005
Last Updated:   September 25, 2008
ClinicalTrials.gov Identifier:   NCT00183287
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 29, 2008




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