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

Overview

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.

Full Title of Study: “Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2013

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.

Clinical Trial Outcome Measures

Primary Measures

  • Successive suppressed viral load measures
    • Time Frame: Measured 144 weeks after randomization
  • Genotypic or phenotypic resistance
    • Time Frame: Measured at baseline and study completion
  • 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
  • Absolute number and percentage of CD4 and CD8 T cells
    • Time Frame: Measured 144 weeks after randomization
  • Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells
    • Time Frame: Measured 144 weeks after randomization
  • Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells
    • Time Frame: Measured 144 weeks after randomization
  • Levels of immune activation markers, including CD8, CD38, and HLA-DR cells
    • Time Frame: Measured 144 weeks after randomization

Secondary Measures

  • HIV-1 latency or replication in tissue or cellular reservoirs
    • Time Frame: Measured at baseline, Week 16, Week 48, and study completion
  • Syncytium and non-syncytium inducing (SI/NSI) phenotype
    • Time Frame: Measured at baseline, Week 16, Week 48, and study completion
  • Metabolic and neurologic complications
    • Time Frame: Measured at baseline, Week 16, Week 48, and study completion
  • Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV
    • Time Frame: Measured 144 weeks after randomization
  • Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)
    • Time Frame: Measured at baseline, Week 16, and study completion
  • 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
  • Quality of life scores
    • Time Frame: Measured at baseline, Week 48, and study completion
  • Subject-reported patterns of adherence
    • Time Frame: Measured at baseline, Week 48, and study completion
  • Estimated inpatient, outpatient, and total costs
    • Time Frame: Measured at study completion

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AIDS Clinical Trials Group
  • Collaborator
    • National Institute of Allergy and Infectious Diseases (NIAID)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Constance A. Benson, MD, Study Chair, Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
    • Ann C. Collier, MD, Study Chair, University of Washington

References

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. doi: 10.2174/138161206776055813.

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. doi: 10.1111/j.1468-1293.2005.00268.x.

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