HIV-1 Infection Clinical Trial
Official title:
A Randomized, Double-Blinded, Placebo-Controlled Trial of a Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin, Januvia) for Reducing Inflammation and Immune Activation in HIV-Infected Men and Women: A Multicenter Trial of the AIDS Clinical Trials Group (ACTG)
The purpose of the study is to evaluate whether sitagliptin (Januvia is the brand name for sitagliptin) reduces inflammation and immune activation markers in HIV-infected men and women when compared to a placebo (inactive medication like a dummy pill). The study evaluated whether taking 100 mg of sitagliptin by mouth daily for 16 weeks is safe and effective for HIV-infected persons on antiretroviral therapy (ART) who do not have diabetes. Sitagliptin is a medication that is used to treat people with diabetes (high blood sugar) but also may reduce inflammation in the body.
ACTG A5346 is a phase II, randomized, double-blinded, placebo-controlled, trial of sitagliptin 100 mg vs. placebo for 16 weeks followed by a 4-week post-intervention follow-up. A5346 studied whether sitagliptin reduced plasma concentrations of sCD14 in HIV-infected men and women ≥18 years of age who were on suppressive ART with HIV-1 RNA below the limit of quantification at screening and for at least the prior 48 weeks. Participants were randomized 1:1 to Sitagliptin arm vs. Placebo arm, and were stratified by screening CD4 count (100-350 vs. >350 cells/mm^3) and statin use (on statins vs. not on statins). ;
| 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 | |
| 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 |
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 |
NCT01704781 -
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
|
Phase 1/Phase 2 | |
| Completed |
NCT01627678 -
Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on 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 | |
| Completed |
NCT02174159 -
Evaluation of Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Ulonivirine (MK-8507) in Human Immunodeficiency Virus (HIV-1)-Infected Participants (MK-8507-003)
|
Phase 1 |