Conditions: HIV Infections Acquired Immunodeficiency Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 206
Healthy volunteers: no

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

Detailed 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.

Arms:
arm 1: MK0518 600 mg twice daily arm 2: MK0518 400 mg twice daily arm 3: MK0518 200 mg twice daily arm 4: MK0518 100 mg twice daily arm 5: Placebo to MK0518 twice daily arm 6: MK0518 600 mg + tenofovir + lamivudine arm 7: MK0518 400 mg + tenofovir + lamivudine arm 8: MK0518 200 mg + tenofovir + lamivudine arm 9: MK0518 100 mg + tenofovir + lamivudine arm 10: efavirenz + tenofovir + lamivudine

Interventions: intervention 1: Comparator: MK0518 monotherapy intervention 2: Comparator: MK0518 combination therapy intervention 3: Comparator: efavirenz intervention 4: Comparator: tenofovir intervention 5: Comparator: lamivudine intervention 6: Placebo monotherapy
Intervention descriptions: intervention 1: MK0518 twice daily for 10 days intervention 2: MK0518 twice daily for 48 weeks intervention 3: efavirenz 600 mg every night at bedtime for 48 weeks intervention 4: tenofovir 300 mg daily for 48 weeks intervention 5: lamivudine 300 mg daily for 48 weeks intervention 6: Placebo to MK0518 twice daily

Protocol document: