Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

ViiV Healthcare

Status and phase: Completed; Phase 2

Conditions: HIV

Treatments: Drug: Maraviroc (UK-427,857); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00634959

A4001015

Details and patient eligibility

About

To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)

Enrollment: 37 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asymptomatic HIV-1 infected male and female patients
• Weight between 50 and 100kg and within the permitted range for their height
• Patients with virus that targets CCR5 receptor

Exclusion criteria

• Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL
• Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
• Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
• Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

2

Experimental group

Treatment:

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

3

Experimental group

Treatment:

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

4

Experimental group

Treatment:

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

5

Placebo Comparator group

Treatment:

Other: Placebo