Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
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ClinicalTrials.gov Identifier: NCT01140412 |
Recruitment Status
:
Terminated
(The trial prematurely terminated on November 1, 2010, due to healthy volunteer participants experiencing non-serious fosamprenavir-related skin rash.)
First Posted
: June 9, 2010
Last Update Posted
: February 4, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Maraviroc Drug: Fosamprenavir/ritonavir Drug: Maraviroc + Fosamprenavir/ritonavir | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label, Fixed-Sequence, Crossover Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
Twice daily regimen
|
Drug: Maraviroc
maraviroc 300 mg BID x 5 days
Other Name: Selzentry, Celsentri
Drug: Fosamprenavir/ritonavir
fosamprenavir/ritonavir 700/100 mg BID x 10 days
Drug: Maraviroc + Fosamprenavir/ritonavir
maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days
|
Experimental: Cohort 2
Once daily regimen
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Drug: Maraviroc
maraviroc 300 mg QD x 5 days
Other Name: Selzentry, Celsentri
Drug: Fosamprenavir/ritonavir
fosamprenavir/ritonavir 1400/100 mg QD x 10 days
Drug: Maraviroc + Fosamprenavir/ritonavir
maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days
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- Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20 [ Time Frame: 25 days ]
- Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20 [ Time Frame: 25 days ]
- Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. [ Time Frame: 25 days ]
- Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. [ Time Frame: 25 days ]
- Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments. [ Time Frame: 25 days ]

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight >45 kg (99 lbs).
Exclusion Criteria:
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- Known hypersensitivity or history of allergy to sulfonamides.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140412
Singapore | |
Pfizer Investigational Site | |
Singapore, Singapore, 188770 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT01140412 History of Changes |
Other Study ID Numbers: |
A4001099 |
First Posted: | June 9, 2010 Key Record Dates |
Last Update Posted: | February 4, 2011 |
Last Verified: | February 2011 |
Keywords provided by ViiV Healthcare:
maraviroc fosamprenavir drug interaction pharmacokinetics |
HIV AIDS CCR5 protease inhibitor |
Additional relevant MeSH terms:
Ritonavir Fosamprenavir Maraviroc HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors CCR5 Receptor Antagonists |