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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00001137
First received: January 28, 2000
Last updated: December 5, 2013
Last verified: December 2013
  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:


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 ]

Enrollment: 5982
Study Start Date: January 2000
Study Completion Date: November 2013
Primary Completion Date: November 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
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: NCT00001137

  Show 77 Study Locations
Sponsors and Collaborators
AIDS Clinical Trials Group
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: December 5, 2013
Health Authority: United States: Federal Government

Keywords provided by AIDS Clinical Trials Group:
AIDS-Related Opportunistic Infections
Treatment Experienced
Treatment Naive
Virus Replication
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
Infection
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 20, 2014