Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers

St Stephens Aids Trust

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Maraviroc

Study type: Interventional

Funder types: Other

Identifiers

NCT00771823

SSAT025

2007-004477-25 (EudraCT Number)

Details and patient eligibility

About

A placebo controlled study of the impact on insulin sensitivity and lipid profile of maraviroc 300 mg twice daily in HIV negative male volunteers.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must have documented negative HIV serology by ELISA and P24 antigen
• Subjects must be clinically well males aged between 18 to 60 years.
• Fasting blood glucose, total cholesterol and triglycerides within normal limits
• Hepatic transaminases (AST and ALT) ≤ 3 × upper limit of normal (ULN)
• Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dL)
• Serum amylase ≤ 1.5 × ULN
• Sexually active males must use condoms during the course of the study
• Life expectancy ≥ 1 year
• Willing and able to provide informed consent

Exclusion criteria

• Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded

• Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)

• Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)

• Other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension.

• Receiving on-going therapy with any of the following:

  • Metabolically active medications
  • Any lipid-lowering medication
  • Hormonal agents (oestrogens or androgens)
  • Glucocorticoids
  • Beta-blockers
  • Thiazide diuretics
  • Thyroid preparations
  • Psychotropic agents
  • Anabolic steroids
  • Megestrol acetate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

2

Active Comparator group

Treatment:

Drug: Maraviroc

Drug: Maraviroc

1

Active Comparator group

Description:

* Maraviroc 300 mg twice daily for the first 14 days of the study. * Placebo twice daily for the last 14 days of the study

Treatment:

Drug: Maraviroc

Drug: Maraviroc