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

History of Changes

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


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

Biospecimen Retention: Samples With DNA

Blood collection


Estimated Enrollment:	150
Study Completion Date:	March 2003

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00183287 History of Changes
Other Study ID Numbers:	IRP 020 11754
Study First Received:	September 13, 2005
Last Updated:	April 25, 2012
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 29, 2016

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