Clinical Trials Logo

Clinical Trial Summary

Aging with HIV may be related to an earlier development of frailty (weakness) or disability, including difficulties in tests of strength or walking speed. Few treatments have been shown to prevent or slow these impairments in people with or without HIV. Some studies have suggested that the class of drugs called statins (for example, pitavastatin) might be helpful in slowing frailty or disability. This might happen by decreasing fat within the muscle or by decreasing inflammation markers (substances in the blood that determine how the body reacts to infection or irritation) in the blood. Other studies have shown that statins increase the risk of muscle aches and pains. This substudy is being done to determine the impact of the drug pitavastatin on muscle.


Clinical Trial Description

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants enrolled in both REPRIEVE (A5332) and its mechanistic sub-study A5333s or in REPRIEVE (A5332) alone and follow them for 48 months after entry to REPRIEVE (A5332). Treatment groups (pitavastatin vs placebo) will be defined according to randomization in REPRIEVE (A5332). No intervention will be provided in this sub-study. Study visits are scheduled at PREPARE (A5361s) entry and at months 12, 24, 36 and 48 after REPRIEVE (A5332) entry. Each study visit will include evaluation of physical function, frailty and self-reported physical activity and sedentary time. In addition, demographic and clinical data, laboratory specimens and CT scans collected as part of the main study REPRIEVE (A5332) or its mechanistic sub-study A5333s will be used. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03070223
Study type Observational
Source AIDS Clinical Trials Group
Contact
Status Completed
Phase
Start date February 28, 2017
Completion date August 21, 2023

See also
  Status Clinical Trial Phase
Completed NCT03188523 - Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002) Phase 1
Active, not recruiting NCT06185452 - Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine Phase 4
Recruiting NCT02881320 - Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 Phase 2/Phase 3
Completed NCT02542852 - A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia Phase 2
Completed NCT02513771 - Sitagliptin for Reducing Inflammation and Immune Activation Phase 2
Completed NCT02057796 - Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3 Phase 4
Terminated NCT02732457 - Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
Completed NCT01989910 - Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients Phase 4
Completed NCT01627678 - Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART Phase 1/Phase 2
Completed NCT01704781 - Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART) Phase 1/Phase 2
Completed NCT01466595 - Rifaximin as a Modulator of Microbial Translocation and Immune Activation Phase 2
Completed NCT01403051 - High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART Phase 2
Completed NCT01348308 - Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients Phase 3
Completed NCT01019551 - Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients Phase 2
Completed NCT01511809 - Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression Phase 3
Terminated NCT01130376 - Novel Interventions in HIV-1 Infection Phase 1
Completed NCT00323687 - SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada Phase 4
Completed NCT04003103 - Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016) Phase 2
Completed NCT02527096 - A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol) Phase 2
Active, not recruiting NCT04776252 - Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) Phase 3