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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00098293 |
Purpose
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 |
Drug: Maraviroc + Zidovudine/Lamivudine Drug: Efavirenz + Zidovudine/Lamivudine Drug: Maraviroc (UK-427,857) + Zidovudine/Lamivudine |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Randomized, Double-Blind, Comparative Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Zidovudine/Lamivudine Versus Efavirenz In Combination With Zidovudine/Lamivudine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects |
| Enrollment: | 898 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | June 2011 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Maraviroc + Zidovudine/Lamivudine
maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
|
| 3: Active Comparator |
Drug: Efavirenz + Zidovudine/Lamivudine
efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)
|
|
2: Experimental
Following a review of the interim analysis data, the DSMB recommended to terminate the UK-427,857 300 mg QD arm based on pre-specified protocol non-inferiority criteria not being met for the QD arm versus efavirenz
|
Drug: Maraviroc (UK-427,857) + Zidovudine/Lamivudine
maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35233 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294-2050 | |
| United States, California | |
| Pfizer Investigational Site | |
| Beverly Hills, California, United States, 90211 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90069 | |
| Pfizer Investigational Site | |
| Oakland, California, United States, 94602 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90048 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90022 | |
| Pfizer Investigational Site | |
| Newport Beach, California, United States, 92663 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90048 | |
| Pfizer Investigational Site | |
| Sacramento, California, United States, 95825 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115-3029 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32209 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32803 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33136 | |
| Pfizer Investigational Site | |
| Miami Beach, Florida, United States, 33139 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33133 | |
| Pfizer Investigational Site | |
| Sarasota, Florida, United States, 34243 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02111 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02118-2393 | |
| Pfizer Investigational Site | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68106 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Albany, New York, United States, 12208 | |
| Pfizer Investigational Site | |
| Brooklyn, New York, United States, 11203 | |
| Pfizer Investigational Site | |
| Flushing, New York, United States, 11355 | |
| Pfizer Investigational Site | |
| Manhasset, New York, United States, 11030 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Huntersville, North Carolina, United States, 28078 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45267-0405 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73104-5068 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Columbia, South Carolina, United States, 29206 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75208 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77006 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77098 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Annandale, Virginia, United States, 22003 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Puyallup, Washington, United States, 98372 | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| Argentina | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina | |
| Pfizer Investigational Site | |
| Ciudad de Buenos, Argentina, C1282AEN | |
| Pfizer Investigational Site | |
| Ciudad de Buenos Aires, Argentina, C1202ABB | |
| Pfizer Investigational Site | |
| Ciudad de Buenos Aires, Argentina, C1406FWY | |
| Pfizer Investigational Site | |
| Ciudad de Buenos Aires, Argentina | |
| Pfizer Investigational Site | |
| Provincia de Buenos Aires, Argentina | |
| Pfizer Investigational Site | |
| Provincia de Santa Fe, Argentina | |
| Argentina, Provincia de Buenos Aires | |
| Pfizer Investigational Site | |
| El Palomar, Provincia de Buenos Aires, Argentina, B1685HOE | |
| Argentina, Provincia de Neuquen | |
| Pfizer Investigational Site | |
| Neuquen, Provincia de Neuquen, Argentina, Q8300PMB | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Burwood, New South Wales, Australia, 2134 | |
| Pfizer Investigational Site | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Pfizer Investigational Site | |
| Sydney, New South Wales, Australia, 2010 | |
| Pfizer Investigational Site | |
| Wentworthville, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Herston, Queensland, Australia, 4029 | |
| Pfizer Investigational Site | |
| Miami, Queensland, Australia, 4220 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Carlton, Victoria, Australia, 3053 | |
| Pfizer Investigational Site | |
| Melbourne, Victoria, Australia, 3004 | |
| Pfizer Investigational Site | |
| North Fitzroy, Victoria, Australia, 3068 | |
| Pfizer Investigational Site | |
| South Yarra, Victoria, Australia, 3141 | |
| Belgium | |
| Pfizer Investigational Site | |
| Brussels, Belgium, 1000 | |
| Pfizer Investigational Site | |
| Brussels, Belgium, 1200 | |
| Pfizer Investigational Site | |
| Gent, Belgium, 9000 | |
| Pfizer Investigational Site | |
| Leuven, Belgium, B-3000 Leuven | |
| Brazil, RJ | |
| Pfizer Investigational Site | |
| Rio de Janeiro, RJ, Brazil, 20210-030 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2R0X7 | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V6B 1R3 | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V6Z 2C7 | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V6Z 2T1 | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 5B1 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 4P9 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2X 2P4 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Pfizer Investigational Site | |
| Sainte-Foy, Quebec, Canada, G1V 4G2 | |
| Italy | |
| Pfizer Investigational Site | |
| Antella (fi), Italy, 50011 | |
| Pfizer Investigational Site | |
| Brescia, Italy, 25123 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20100 | |
| Pfizer Investigational Site | |
| Modena, Italy, 41100 | |
| Pfizer Investigational Site | |
| Roma, Italy | |
| Pfizer Investigational Site | |
| Roma, Italy, 00185 | |
| Pfizer Investigational Site | |
| Torino, Italy, 10149 | |
| Pfizer Investigational Site | |
| Torino, Italy, 10149 | |
| Mexico, Mexico City | |
| Pfizer Investigational Site | |
| Del. Tlalpan C.p., Mexico City, Mexico, 14050 | |
| Mexico, Mexico D.F. | |
| Pfizer Investigational Site | |
| Del. Tlalpan, C.p., Mexico D.F., Mexico, 14000 | |
| Pfizer Investigational Site | |
| Del. Tlalpan, C.p., Mexico D.F., Mexico, 14080 | |
| Pfizer Investigational Site | |
| Delegacion Tlalpan C. P, Mexico D.F., Mexico, 14080 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1091 AC | |
| Pfizer Investigational Site | |
| Rotterdam, Netherlands, 3015 GD | |
| Pfizer Investigational Site | |
| Utrecht, Netherlands, 3584 CX | |
| Poland | |
| Pfizer Investigational Site | |
| Gdansk, Poland, 80-214 | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85-030 | |
| Pfizer Investigational Site | |
| Chorzow, Poland, 41-500 | |
| Pfizer Investigational Site | |
| Bialystok, Poland, 15-540 | |
| Pfizer Investigational Site | |
| Krakow, Poland, 31-531 | |
| Pfizer Investigational Site | |
| Szczecin, Poland, 71-455 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 01-201 | |
| Puerto Rico | |
| Pfizer Investigational Site | |
| Rio Piedras, Puerto Rico, 00935 | |
| Pfizer Investigational Site | |
| San Juan, Puerto Rico, 00909 | |
| Pfizer Investigational Site | |
| San Juan, Puerto Rico, 00935 | |
| Pfizer Investigational Site | |
| Stop 15, San Juan, Puerto Rico, 00909 | |
| Pfizer Investigational Site | |
| Ponce, Puerto Rico, 00731 | |
| South Africa | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7705 | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7405 | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7780 | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7550 | |
| Pfizer Investigational Site | |
| Johannesburg, South Africa, 2047 | |
| Pfizer Investigational Site | |
| Port Elizabeth, South Africa, 6001 | |
| Pfizer Investigational Site | |
| Pretoria, South Africa, 0132 | |
| Pfizer Investigational Site | |
| Pretoria North, South Africa, 0162 | |
| South Africa, Free State | |
| Pfizer Investigational Site | |
| Bloomfontein, Free State, South Africa, 9301 | |
| South Africa, Gauteng | |
| Pfizer Investigational Site | |
| Johannesburg, Gauteng, South Africa, 2092 | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng, South Africa, 0083 | |
| South Africa, Johannesburg | |
| Pfizer Investigational Site | |
| Soweto, Johannesburg, South Africa, 2013 | |
| South Africa, KwaZulu Natal | |
| Pfizer Investigational Site | |
| Dundee, KwaZulu Natal, South Africa, 3000 | |
| Switzerland | |
| Pfizer Investigational Site | |
| 1211 Genève, Switzerland, 14 | |
| Pfizer Investigational Site | |
| Basel, Switzerland, 4031 | |
| Pfizer Investigational Site | |
| Bern, Switzerland, 3010 | |
| Pfizer Investigational Site | |
| Zürich, Switzerland, 8038 | |
| Pfizer Investigational Site | |
| St. Gallen, Switzerland, 9007 | |
| Pfizer Investigational Site | |
| Zürich, Switzerland, 8091 | |
| Pfizer Investigational Site | |
| Lugano, Switzerland, 6900 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Birmingham, United Kingdom, B9 5SS | |
| Pfizer Investigational Site | |
| Brighton, United Kingdom, BN2 1ES | |
| Pfizer Investigational Site | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE5 9RS | |
| Pfizer Investigational Site | |
| London, United Kingdom, SW10 9NH | |
| Pfizer Investigational Site | |
| London, United Kingdom, NW3 2QG | |
| Pfizer Investigational Site | |
| London, United Kingdom, W2 1NY | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M8 5RB | |
| United Kingdom, LOTH | |
| Pfizer Investigational Site | |
| Edinburgh, LOTH, United Kingdom, ED4 2XU | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A4001026 |
| Study First Received: | December 6, 2004 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00098293 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Aids HIV |
|
Antimetabolites Efavirenz Anti-Infective Agents Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine |
Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |