Clinical Trials Logo

Clinical Trial Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of monotherapy with MK-8504 (a tenofovir pro-drug), in ART-naïve Human Immunodeficiency Virus (HIV)-1 infected participants. The primary hypothesis is that MK-8504, at a dose that is sufficiently safe and well tolerated, has superior antiretroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours post-dose.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03188523
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 1
Start date September 8, 2017
Completion date June 4, 2018

See also
  Status Clinical Trial Phase
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
Terminated NCT02732457 - Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
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
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 NCT01348308 - Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients Phase 3
Completed NCT01403051 - High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART Phase 2
Completed NCT01466595 - Rifaximin as a Modulator of Microbial Translocation and Immune Activation Phase 2
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