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

Sponsor:	AIDS Clinical Trials Group
Collaborator:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):	AIDS Clinical Trials Group
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

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

U.S. FDA Resources

Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures:

Successive suppressed viral load measures [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: Yes ]
Genotypic or phenotypic resistance [ Time Frame: Measured at baseline and study completion ] [ Designated as safety issue: No ]
Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater [ Time Frame: Measured throughout ] [ Designated as safety issue: Yes ]
Absolute number and percentage of CD4 and CD8 T cells [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]
Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]
Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]
Levels of immune activation markers, including CD8, CD38, and HLA-DR cells [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HIV-1 latency or replication in tissue or cellular reservoirs [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ] [ Designated as safety issue: No ]
Syncytium and non-syncytium inducing (SI/NSI) phenotype [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ] [ Designated as safety issue: No ]
Metabolic and neurologic complications [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ] [ Designated as safety issue: Yes ]
Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]
Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs) [ Time Frame: Measured at baseline, Week 16, and study completion ] [ Designated as safety issue: No ]
Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities [ Time Frame: Measured at baseline, Week 48, and study completion ] [ Designated as safety issue: Yes ]
Quality of life scores [ Time Frame: Measured at baseline, Week 48, and study completion ] [ Designated as safety issue: No ]
Subject-reported patterns of adherence [ Time Frame: Measured at baseline, Week 48, and study completion ] [ Designated as safety issue: No ]
Estimated inpatient, outpatient, and total costs [ Time Frame: Measured at study completion ] [ Designated as safety issue: No ]

Estimated Enrollment:	6100
Study Start Date:	January 2000
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

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, including the visit window 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 77 Study Locations

Sponsors and Collaborators

AIDS Clinical Trials Group

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

Additional 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lok JJ, Bosch RJ, Benson CA, Collier AC, Robbins GK, Shafer RW, Hughes MD; ALLRT team. Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection. AIDS. 2010 Jul 31;24(12):1867-76.

Responsible Party:	AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:	NCT00001137 History of Changes
Other Study ID Numbers:	ACTG A5001, 1U01AI068636, AACTG A5001
Study First Received:	January 28, 2000
Last Updated:	January 19, 2012
Health Authority:	United States: Federal Government

Keywords provided by AIDS Clinical Trials Group:

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
Neurologic Symptoms

Additional relevant MeSH terms:

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 February 09, 2012