Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

601

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

April 30, 2007

Study Completion Date

April 30, 2011

Conditions
HIV Infections
Interventions
DRUG

Maraviroc (UK-427,857)

Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy

DRUG

Optimized Background Therapy

Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy

DRUG

Optimized Background Therapy

Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \[OBT (3-6 drugs based on treatment history and resistance testing)\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.

DRUG

Placebo

Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \[OBT (3-6 drugs based on treatment history and resistance testing)\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.

DRUG

Optimized Background Therapy

Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \[OBT (3-6 drugs based on treatment history and resistance testing)\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment.

Trial Locations (22)

10003

Pfizer Investigational Site, New York

10467

Pfizer Investigational Site, The Bronx

14642

Pfizer Investigational Site, Rochester

20036

Pfizer Investigational Site, Washington D.C.

22003

Pfizer Investigational Site, Annandale

30308

Pfizer Investigational Site, Atlanta

32960

Pfizer Investigational Site, Vero Beach

33602

Pfizer Investigational Site, Tampa

33614

Pfizer Investigational Site, Tampa

70112

Pfizer Investigational Site, New Orleans

78705

Pfizer Investigational Site, Austin

80045

Pfizer Investigational Site, Auroa

Pfizer Investigational Site, Aurora

87505

Pfizer Investigational Site, Santa Fe

94115

Pfizer Investigational Site, San Francisco

94118

Pfizer Investigational Site, San Francisco

94121

Pfizer Investigational Site, San Francisco

95825

Pfizer Investigational Site, Sacramento

97219

Pfizer Investigational Site, Portland

45267-0405

Pfizer Investigational Site, Cincinnati

V6Z 1Y6

Pfizer Investigational Site, Vancouver

H2L 4P9

Pfizer Investigational Site, Montreal

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

ViiV Healthcare

INDUSTRY