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

Conditions

HIV Infections

Keywords

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

Brief summary

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.

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.

Mohammed Siddiqui, Tony Moore, Dustin M. Long, Greer Burkholder, Amanda L. Willig et al. (9 authors)

AIDS Research and Human Retroviruses2022-07-026 citations

10.1089/aid.2021.0213

Changes in Inflammation but Not in T-Cell Activation Precede Non-AIDS-Defining Events in a Case-Control Study of Patients on Long-term Antiretroviral Therapy

Konstantia Angelidou, Peter W. Hunt, Alan Landay, Cara C. Wilson, Benigno Rodríguez et al. (8 authors)

The Journal of Infectious Diseases2017-11-2231 citations

10.1093/infdis/jix666

Continued Slow Decay of the Residual Plasma Viremia Level in HIV-1<i>–</i>Infected Adults Receiving Long-term Antiretroviral Therapy

Sharon A. Riddler, Evgenia Aga, Ronald J. Bosch, Barbara Bastow, Margaret A Bedison et al. (10 authors)

The Journal of Infectious Diseases2015-09-0249 citations

10.1093/infdis/jiv433

HIV-1 DNA Decay Dynamics in Blood During More Than a Decade of Suppressive Antiretroviral Therapy

Guillaume Besson, Christina M. Lalama, Ronald J. Bosch, Rajesh T. Gandhi, Margaret A Bedison et al. (10 authors)

Clinical Infectious Diseases2014-07-29222 citations

10.1093/cid/ciu585

Soluble Markers of Inflammation and Coagulation but Not T-Cell Activation Predict Non–AIDS-Defining Morbid Events During Suppressive Antiretroviral Treatment

Allan R. Tenorio, Yu Zheng, Ronald J. Bosch, Supriya Krishnan, Benigno Rodríguez et al. (12 authors)

The Journal of Infectious Diseases2014-05-01529 citations

10.1093/infdis/jiu254

Impact of Chemotherapy for HIV-1 Related Lymphoma on Residual Viremia and Cellular HIV-1 DNA in Patients on Suppressive Antiretroviral Therapy

Anthony R. Cillo, Supriya Krishnan, Deborah K. McMahon, Ronald T. Mitsuyasu, Michael F. Para et al. (6 authors)

PLoS ONE2014-03-1728 citations

10.1371/journal.pone.0092118

Anthropometric Differences between HIV-Infected Individuals Prior to Antiretroviral Treatment and the General Population from 1998–2007: The AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Cohort and NHANES

Benjamin Atkinson, Supriya Krishnan, Gary M. Cox, Todd Hulgan, Ann C. Collier

PLoS ONE2013-06-036 citations

10.1371/journal.pone.0065306

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Subject-reported patterns of adherence	Measured at baseline, Week 48, and study completion
HIV-1 latency or replication in tissue or cellular reservoirs	Measured at baseline, Week 16, Week 48, and study completion
Estimated inpatient, outpatient, and total costs	Measured at study completion
Syncytium and non-syncytium inducing (SI/NSI) phenotype	Measured at baseline, Week 16, Week 48, and study completion
Metabolic and neurologic complications	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	Measured 144 weeks after randomization
Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)	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	Measured at baseline, Week 48, and study completion
Quality of life scores	Measured at baseline, Week 48, and study completion

Countries

Puerto Rico, United States

Outcome results