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

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ClinicalTrials.gov Identifier: NCT00183287
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 26, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
HIV Infections

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.


Study Design
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Study Type : Observational
Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical, Virologic, and Immunologic Evaluation and Monitoring of Patients With Known or Suspected HIV Infection
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA
Blood collection

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00183287


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: JoAnn M. Mican, MD Laboratory of Immunoregulation (LIR), NIAID
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00183287     History of Changes
Other Study ID Numbers: IRP 020
11754 ( Registry Identifier: DAIDS ES Registry ID )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Infection
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