Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

This study is currently recruiting participants.

Verified by National Institute of Allergy and Infectious Diseases (NIAID), December 2008

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001137

Purpose

The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.

Condition
HIV Infections

MedlinePlus related topics: AIDS AIDS Medicines

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

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

Estimated Enrollment:	4500
Study Start Date:	January 2000

Detailed Description:

A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.

No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants in this study will be HIV infected men and women who are enrolled in an ACTG parent study and are receiving HAART.

Criteria

Inclusion Criteria

HIV-1 infected
Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study. More information on this criterion can be found in the protocol.
Willing to provide consent for the release and use of clinical data from the parent study
Life expectancy of at least 24 weeks
Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria

Active alcohol or drug abuse that may interfere with the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001137

Show 65 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Constance A. Benson, MD	Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
Study Chair:	Ann C. Collier, MD	University of Washington, Harborview Medical Center

More Information

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

Publications:

Jain R, Clark NM, Diaz-Linares M, Grim SA. Limitations of current antiretroviral agents and opportunities for development. Curr Pharm Des. 2006;12(9):1065-74. Review.

Torre D, Speranza F, Martegani R. Impact of highly active antiretroviral therapy on organ-specific manifestations of HIV-1 infection. HIV Med. 2005 Mar;6(2):66-78. Review.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	ACTG A5001, AACTG A5001
Study First Received:	January 28, 2000
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00001137
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Treatment Experienced
Treatment Naive
Virus Replication
AIDS-Related Opportunistic Infections
HIV-1
Risk Factors
Incidence

RNA, Viral
Anti-HIV Agents
Viral Load
Lipodystrophy
Nervous System
Cardiovascular System

Study placed in the following topic categories:

Virus Diseases
Opportunistic Infections
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Lipodystrophy
Acquired Immunodeficiency Syndrome
AIDS-Related Opportunistic Infections
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009