Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

ViiV Healthcare

Status and phase: Completed; Phase 2

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643643

A4001007

Details and patient eligibility

About

To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).

Enrollment: 41 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion criteria:

• Male with HIV or surgically sterilized female with HIV showing no symptoms of HIV
• Weight between 50 and 90kg and within the permitted range for their height

Exclusion criteria

Exclusion criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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41 participants in 5 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

B

Experimental group

Treatment:

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

C

Experimental group

Treatment:

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

D

Experimental group

Treatment:

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

Drug: Maraviroc (UK-427,857)

E

Placebo Comparator group

Treatment:

Other: Placebo