The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study

NCT01348763 | Completed Phase 1 Results

• 2 other identifiers: MRV_DRV_PK2009-014924-42
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day

  On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured .

  10 day, 20 days

Secondary Outcomes (1)

• Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests

  35 days

Study Arms (1)

Truvada, Darunavir/r and Maraviroc

EXPERIMENTAL

Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada

Drug: Maraviroc; Drug: Truvada; Drug: Darunavir

Interventions

Maraviroc DRUG

Maraviroc 150 mg daily

Truvada, Darunavir/r and Maraviroc

Truvada DRUG

daily until 10. day then stop

Truvada, Darunavir/r and Maraviroc

Darunavir DRUG

daily until 10. day then stop

Truvada, Darunavir/r and Maraviroc

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: male only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• current alcohol abuse or drug dependence
• positive urine drug of abuse screening
• pregnancy
• active opportunistic infection or significant co-morbidities
• current disallowed concomitant medication

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• Mora-Peris B, Croucher A, Else LJ, Vera JH, Khoo S, Scullard G, Back D, Winston A. Pharmacokinetic profile and safety of 150 mg of maraviroc dosed with 800/100 mg of darunavir/ritonavir all once daily, with and without nucleoside analogues, in HIV-infected subjects. J Antimicrob Chemother. 2013 Jun;68(6):1348-53. doi: 10.1093/jac/dkt006. Epub 2013 Jan 30.

  PMID: 23364475 RESULT

MeSH Terms

Interventions

Maraviroc; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Darunavir

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tenofovir; Organophosphonates; Organophosphorus Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Sulfonamides; Amides; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans

Results Point of Contact

• Title: Alan Winston
• Organization: Imperial College London

a.winston@imperial.ac.uk

+442033121603

Study Officials

• Alan Winston, MB BH

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: May 5, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 31, 2019
• Results First Posted: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)