The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects currently attending for HIV care at St. Mary's Hospital, London will be eligible.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Darunavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc; Ritonavir

Criteria

Inclusion Criteria:

• HIV-1 infected males or females

• signed informed consent

• plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months

• currently receiving an antiretroviral regimen comprising of: tenofovir 245 mg daily,emtricitabine 200 mg daily, darunavir 800 mg daily and ritonavir 100 mg daily

• no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing if an HIV resistance test available

• Between 18 to 65 years of age, inclusive

• subjects in good health upon medical history, physical exam, and laboratory testing

• BMI above or equal to 18 and below 32

• Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening until 8 weeks after completion of the study:

• barrier contraceptives (condom OR diaphragm PLUS spermicide) or oral, implant or injectable hormonal contraceptive PLUS a barrier contraceptive or

• IUD /IUS PLUS a barrier contraceptive

• Female subjects of childbearing potential must have a negative urine pregnancy test.

• Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study.

• Have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection evidenced by a negative HCV antibody at screening.

• Have screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance

• CCR5 tropic HIV virus based on a genotypic tropism assay from either a stored plasma sample where available or fresh plasma

Exclusion Criteria:

• current alcohol abuse or drug dependence

• positive urine drug of abuse screening

• pregnancy

• active opportunistic infection or significant co-morbidities

• current disallowed concomitant medication