The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study
This study is not yet open for participant recruitment.
Verified December 2011 by Imperial College London
Sponsor:
Imperial College London
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01348763
First received: March 25, 2011
Last updated: December 22, 2011
Last verified: December 2011
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Purpose
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.
The study will describe the steady state pharmacokinetic parameters and short term safety of maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects.
Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving antiretroviral therapy comprising:
- tenofovir/emtricitabine 245/200 mg daily plus
- darunavir/ritonavir 800/100 mg daily
On day 1, subjects will modify their current antiretroviral therapy to the following:
- tenofovir/emtricitabine 245/200 mg daily plus
- darunavir/ritonavir 800/100 mg daily plus
- maraviroc 150 mg daily On day 10 subjects will undergo an intensive pharmacokinetic visit.
On day 11, subjects will modify their current antiretroviral therapy to the following:
- darunavir/ritonavir 800/100 mg daily plus
- maraviroc 150 mg daily (i.e. tenofovir/emtricitabine will be discontinued) On day 20 subjects will undergo an intensive pharmacokinetic visit. Following completion of this study phase, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Maraviroc |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Phase 1 Pharmacokinetic Study to Assess the Steady State Pharmacokinetic Profile and Short Term Safety of Maraviroc Dosed With Darunavir/Ritonavir All Once Daily, With and Without Nucleoside Analogues, in HIV-1 Infected Subjects |
Resource links provided by NLM:
Further study details as provided by Imperial College London:
Primary Outcome Measures:
- maximum plasma concentration [ Time Frame: 20 days ] [ Designated as safety issue: No ]On day 10 of the study the maximum and minimum plasma concentractions of darunavir, ritonavir maraviroc tenofovir and emtricitibine will be measured and the time to reach these levels. On day 20 of the study the maximum and minimum plasma concentractions of darunavir, ritonavir and maraviroc will be measured and the time to reach these levels.
Secondary Outcome Measures:
- Changes in haematology and biochemistry laboratory tests [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]full blood count, elelectrolytes and lipids will be measured to assess for changes
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Truvada, Darunavir/r and Maraviroc
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
Maraviroc 150 mg daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348763
Contacts
| Contact: Alan Winston, MB BS | +44 (0)20 3312 1603 | a.winston@imperial.ac.uk |
| Contact: Ken Legg, BSc | +44 (0)20 3312 1464 | k.legg@imperial.ac.uk |
Locations
| United Kingdom | |
| Imperial College Healthcare NHS Trust | Recruiting |
| London, United Kingdom, W2 1NY | |
| Contact: Alan Winston, MB BH +44 (0)20 3312 1603 a.winston@imperial.ac.uk | |
| Contact: Ken Legg, BSc +44 (0)20 3312 1464 k.legg@imperial.ac.uk | |
Sponsors and Collaborators
Imperial College London
Investigators
| Principal Investigator: | Alan Winston, MB BH | Imperial College London |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01348763 History of Changes |
| Other Study ID Numbers: | MRV_DRV_PK, 2009-014924-42 |
| Study First Received: | March 25, 2011 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Ritonavir Darunavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013