Skip to main content
OpenTrials
Completed

NCT Number: NCT00001137

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections AIDS-Related Opportunistic Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Opportunistic Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Puerto Rico-AIDS CRS, San Juan, Puerto Rico

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Successive suppressed viral load measures

    Time frame: Measured 144 weeks after randomization

  2. Genotypic or phenotypic resistance

    Time frame: Measured at baseline and study completion

  3. 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

  4. Absolute number and percentage of CD4 and CD8 T cells

    Time frame: Measured 144 weeks after randomization

  5. Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells

    Time frame: Measured 144 weeks after randomization

  6. Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells

    Time frame: Measured 144 weeks after randomization

  7. Levels of immune activation markers, including CD8, CD38, and HLA-DR cells

    Time frame: Measured 144 weeks after randomization

Secondary outcomes

  1. HIV-1 latency or replication in tissue or cellular reservoirs

    Time frame: Measured at baseline, Week 16, Week 48, and study completion

  2. Syncytium and non-syncytium inducing (SI/NSI) phenotype

    Time frame: Measured at baseline, Week 16, Week 48, and study completion

  3. Metabolic and neurologic complications

    Time frame: Measured at baseline, Week 16, Week 48, and study completion

  4. Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV

    Time frame: Measured 144 weeks after randomization

  5. Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)

    Time frame: Measured at baseline, Week 16, and study completion

  6. 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

  7. Quality of life scores

    Time frame: Measured at baseline, Week 48, and study completion

  8. Subject-reported patterns of adherence

    Time frame: Measured at baseline, Week 48, and study completion

  9. Estimated inpatient, outpatient, and total costs

    Time frame: Measured at study completion

Sponsors and collaborators

Lead sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Network

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

Important dates

Study start
2000
Primary completion
2013
Study completion
2013
First posted
Aug 31, 2001
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.