Who is sponsoring NCT00100048?

NCT00100048 is sponsored by Merck Sharp & Dohme LLC.

What condition does NCT00100048 study?

NCT00100048 studies HIV Infections, Acquired Immunodeficiency Syndrome.

What drugs are being tested in NCT00100048?

Interventions: Comparator: MK0518 monotherapy, Comparator: MK0518 combination therapy, Comparator: efavirenz, Comparator: tenofovir, Comparator: lamivudine, Placebo monotherapy.

What is the status of NCT00100048?

NCT00100048 is currently COMPLETED.

Last reviewed 2015-09-04 · How we verify

Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients

NCT00100048 Phase 2 COMPLETED Results posted

This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	206
Start date	2005-01
Completion	2010-07

Conditions

HIV Infections
Acquired Immunodeficiency Syndrome

Interventions

Comparator: MK0518 monotherapy
Comparator: MK0518 combination therapy
Comparator: efavirenz
Comparator: tenofovir
Comparator: lamivudine
Placebo monotherapy

Primary outcomes

Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) — Baseline and Day 10
Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)
Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) — 10 days
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) — Week 24
Number of Patients With Clinical Adverse Experiences (CAEs) — 48 weeks
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Number of Patients With Serious CAEs (Cohort I and II Combined) — 48 weeks
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 — 144 Weeks
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product