SWITCH TO MK-1439A FROM A RITONAVIR-BOOSTED PI-CONTAINING REGIMEN IN HIV-1-INFECTED SUBJECTS.

A PHASE III MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE A SWITCH TO MK-1439A IN HIV-1-INFECTED SUBJECTS VIROLOGICALLY SUPPRESSED ON A REGIMEN OF A RITONAVIR-BOOSTED PROTEASE INHIBITOR AND TWO NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIS)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-031-15

Enrollment

Registered

2016-01-11

Start date

2015-10-27

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Treatment Groups: - Immediate Switch Group: Immediate Switch (at Study Day 1) to MK-1439A PO q.d. from a baseline regimen of a ritonavir-boosted protease inhibitor (PI) + 2 nuceloside/nucleotide r

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1 At least 18 years of age 2 Provide written informed consent 3 Have plasma HIV-1 RNA levels BLoQ (<40 copies/mL) 4 Have been receiving antiretroviral therapy with atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir in combination with 2 NRTIs continuously with HIV-1 RNA at undetectable levels for ≥ 6 months prior to visit 1and have no history of prior virologic failure. 5 Be receiving 1st or 2nd PI-based antiretroviral regimen 6 No history of using NNRTI 7 Have a genotype prior to starting initial antiretroviral regimen and have no known resistance to any of the study agents 8 Either no lipid lowering therapy or on a stable dose of lipid lowering therapy 9 Have stable/normal laboratory values 11 Clinically stable 12 Highly unlikely to become pregnant or to impregnate a partner

Exclusion criteria

Exclusion criteria: 1 History or current evidence of any condition, therapy, laboratory abnormality. 2 Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. 3 Has been treated for a viral infection other than HIV-1, with an agent that is active against HIV-1. 4 Has documented or known resistance to study drugs. 5 Has participated in a study with an investigational compound/device. 6 Has used systemic immunosuppressive therapy or immune modulators. 7 Requires using any of the prohibited medications. 8 Has significant hypersensitivity or other contraindication to any of the components of study drugs. 9 Has a current (active) diagnosis of acute hepatitis due to any cause. 10 Is pregnant, breastfeeding, or expecting to conceive. 11 Is expecting to donate eggs or sperm. 12 Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial.

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Guatemala, Israel, Italy, Korea South, Mexico, New Zealand, Poland, Russian Federation, Spain, Switzerland, United Kindgdom, United States

Contacts

Public ContactCecilia Ynouye

MERCK SHARP & DOHME PERU S.R.L

cecilia_ynouye@merck.com411-5904

Outcome results