HIVPhase 1NCT01348763
The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study
A Phase 1 study testing Maraviroc, Truvada and Darunavir in people with HIV, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Maraviroc, Truvada and Darunavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to May 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- current alcohol abuse or drug dependence
- positive urine drug of abuse screening
- pregnancy
- active opportunistic infection or significant co-morbidities
- current disallowed concomitant medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
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
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- Maraviroc, Truvada, Darunavir
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Maraviroc 150 mg daily
TruvadaDrug
daily until 10. day then stop
DarunavirDrug
daily until 10. day then stop
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Maraviroc; Drug: Truvada; Drug: Darunavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 10 day, 20 days
Secondary outcomes (1)
Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests
Haematology and biochemistry laboratory tests such as full blood count, elelectrolytes and lipids will be measured to assess for changes.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Winston, MB BH, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348763
- Sponsor's protocol ID
- MRV_DRV_PK
- Other IDs
- 2009-014924-42, 2009
- Status last verified
- Oct 2019
- First submitted
- 25 Mar 2011
- Last updated
- 31 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23364475
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01348763
- Acronym / sponsor ID
- MRV_DRV_PK
- Conditions
- HIV
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Posted 31 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Truvada, Darunavir/r and Maraviroc | Experimental | Drug: Maraviroc, Drug: Truvada, Drug: DarunavirParticipants 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (5 listed)
- current alcohol abuse or drug dependence
- positive urine drug of abuse screening
- pregnancy
- active opportunistic infection or significant co-morbidities
- current disallowed concomitant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaravirocMaraviroc 150 mg daily | Drug | Truvada, Darunavir/r and Maraviroc |
| Truvadadaily until 10. day then stop | Drug | Truvada, Darunavir/r and Maraviroc |
| Darunavirdaily until 10. day then stop | Drug | Truvada, Darunavir/r and Maraviroc |
Primary outcome
The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day
Time frame: 10 day, 20 days
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 .
1 secondary outcome
Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests
Time frame: 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23364475Mora-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Winston, MB BH principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maraviroc, Truvada and Darunavir in people with HIV, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day (time frame: 10 day, 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.