A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome

Treatments: Drug: Comparator: MK0518 monotherapy; Drug: Placebo monotherapy; Drug: Comparator: MK0518 combination therapy; Drug: Comparator: tenofovir; Drug: Comparator: efavirenz; Drug: Comparator: lamivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00100048

2004_096

0518-004

Details and patient eligibility

About

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

Full description

Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily.

Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must be HIV positive who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy)

Extension Studies:

• First extension: Patient completed the 48-week base study
• Second extension: Patient completed the first 144-week extension study

Exclusion criteria

• Less than 18 years of age
• Individuals who currently do not test positive for HIV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 10 patient groups, including a placebo group

600 mg monotherapy

Experimental group

Description:

MK0518 600 mg twice daily

Treatment:

Drug: Comparator: MK0518 monotherapy

400 mg monotherapy

Experimental group

Description:

MK0518 400 mg twice daily

Treatment:

Drug: Comparator: MK0518 monotherapy

200 mg monotherapy

Experimental group

Description:

MK0518 200 mg twice daily

Treatment:

Drug: Comparator: MK0518 monotherapy

100 mg monotherapy

Experimental group

Description:

MK0518 100 mg twice daily

Treatment:

Drug: Comparator: MK0518 monotherapy

placebo monotherapy

Placebo Comparator group

Description:

Placebo to MK0518 twice daily

Treatment:

Drug: Placebo monotherapy

600 mg combo therapy

Experimental group

Description:

MK0518 600 mg + tenofovir + lamivudine

Treatment:

Drug: Comparator: lamivudine

Drug: Comparator: MK0518 combination therapy

Drug: Comparator: tenofovir

400 mg combo therapy

Experimental group

Description:

MK0518 400 mg + tenofovir + lamivudine

Treatment:

Drug: Comparator: lamivudine

Drug: Comparator: MK0518 combination therapy

Drug: Comparator: tenofovir

200 mg combo therapy

Experimental group

Description:

MK0518 200 mg + tenofovir + lamivudine

Treatment:

Drug: Comparator: lamivudine

Drug: Comparator: MK0518 combination therapy

Drug: Comparator: tenofovir

100 mg combo therapy

Experimental group

Description:

MK0518 100 mg + tenofovir + lamivudine

Treatment:

Drug: Comparator: lamivudine

Drug: Comparator: MK0518 combination therapy

Drug: Comparator: tenofovir

EFV combo therapy

Active Comparator group

Description:

efavirenz + tenofovir + lamivudine

Treatment:

Drug: Comparator: efavirenz

Drug: Comparator: lamivudine

Drug: Comparator: tenofovir