Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

January 28, 2000
December 5, 2013
January 2000
November 2013   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00001137 on Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
Long-Term Data Collection From Participants in Adult AIDS Clinical Trials
Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

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.

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.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

HIV Infections
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2013
November 2013   (final data collection date for primary outcome measure)

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
13 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
ACTG A5001, 1U01AI068636, AACTG A5001
Not Provided
AIDS Clinical Trials Group
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
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
AIDS Clinical Trials Group
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP