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Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine

NCT ID: NCT00098293

Last Updated: 2013-10-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

916 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV-1

Keywords

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Aids HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Maraviroc + Zidovudine/Lamivudine

Intervention Type DRUG

maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)

3

Group Type ACTIVE_COMPARATOR

Efavirenz + Zidovudine/Lamivudine

Intervention Type DRUG

efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)

2

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

Group Type EXPERIMENTAL

Maraviroc (UK-427,857) + Zidovudine/Lamivudine

Intervention Type DRUG

maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)

Interventions

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Maraviroc + Zidovudine/Lamivudine

maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)

Intervention Type DRUG

Efavirenz + Zidovudine/Lamivudine

efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities)
* HIV-1 RNA viral load of greater than or equal to 2, 000 copies/mL
* A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP)
* Effective barrier contraception for WOCBP and males

Exclusion Criteria

* Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy
* Treatment for an active opportunistic infection, or unexplained temperature \>38.5 degrees Celsius for 7 consecutive days
* Prior treatment with efavirenz, zidovudine or lamivudine or with any other antiretroviral therapy for more than 14 days at any time
* Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up
* Lactating women, or planned pregnancy during the trial period
* Suspected primary (acute) HIV-1 infection
* Previous therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 30 days prior to randomization or the expected need for such therapy during the study period
* Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization
* Significantly elevated liver enzymes or cirrhosis
* Significant neutropenia, anemia or thrombocytopenia
* Malabsorption or an inability to tolerate oral medications
* Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease
* Certain medications
* Genotypic or phenotypic resistance to efavirenz, zidovudine or lamivudine
* X4- or dual/mixed-tropic virus or repeated assay failure
* Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Beverly Hills, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Oakland, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Omaha, Nebraska, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Flushing, New York, United States

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Manhasset, New York, United States

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New York, New York, United States

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Huntersville, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Annandale, Virginia, United States

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Puyallup, Washington, United States

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Tacoma, Washington, United States

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El Palomar, Buenos Aires, Argentina

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Neuquén, Neuquén Province, Argentina

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Buenos Aires, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Ciudad de Buenos, , Argentina

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Provincia de Buenos Aires, , Argentina

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Provincia de Santa Fe, , Argentina

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Burwood, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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Surrey Hills, New South Wales, Australia

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Wentworthville, New South Wales, Australia

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Herston, Queensland, Australia

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Miami, Queensland, Australia

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Fitzroy North, Victoria, Australia

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Melbourne, Victoria, Australia

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South Yarra, Victoria, Australia

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Brussels, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Antella (FI), , Italy

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Brescia, , Italy

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Milan, , Italy

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Modena, , Italy

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Roma, , Italy

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Roma, , Italy

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Torino, , Italy

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Del. Tlalpan C.P., Mexico City, Mexico

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Del. Tlalpan, C.P., Mexico City, Mexico

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Del. Tlalpan, C.P., Mexico City, Mexico

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Delegacion Tlalpan C. P, Mexico City, Mexico

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Amsterdam, , Netherlands

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Rotterdam, , Netherlands

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Utrecht, , Netherlands

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Chorzów, , Poland

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Gdansk, , Poland

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Krakow, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Ponce, , Puerto Rico

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Rio Piedras, , Puerto Rico

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San Juan, , Puerto Rico

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San Juan, , Puerto Rico

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Port Elizabeth, Eastern Cape, South Africa

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Dundee, KwaZulu-Natal, South Africa

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Bloomfontein, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Johannesburg, , South Africa

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Pretoria, , South Africa

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Pretoria North, , South Africa

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Soweto, Johannesburg, , South Africa

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Basel, , Switzerland

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Bern, , Switzerland

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Geneva, , Switzerland

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Lugano, , Switzerland

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Sankt Gallen, , Switzerland

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Zurich, , Switzerland

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Zurich, , Switzerland

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Edinburgh, Loth, United Kingdom

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Birmingham, , United Kingdom

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Brighton, , United Kingdom

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Edinburgh, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Countries

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United States Argentina Australia Belgium Brazil Canada Italy Mexico Netherlands Poland Puerto Rico South Africa Switzerland United Kingdom

References

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Vourvahis M, McFadyen L, Nepal S, Valluri SR, Fang A, Fate GD, Wood LS, Marshall JC, Chan PLS, Nedderman A, Haynes J, Savage ME, Clark A, Smith KY, Heera J. No Clinical Impact of CYP3A5 Gene Polymorphisms on the Pharmacokinetics and/or Efficacy of Maraviroc in Healthy Volunteers and HIV-1-Infected Subjects. J Clin Pharmacol. 2019 Jan;59(1):139-152. doi: 10.1002/jcph.1306. Epub 2018 Sep 7.

Reference Type DERIVED
PMID: 30192390 (View on PubMed)

MacInnes A, Lazzarin A, Di Perri G, Sierra-Madero JG, Aberg J, Heera J, Rajicic N, Goodrich J, Mayer H, Valdez H. Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial. HIV Clin Trials. 2011 Jan-Feb;12(1):24-36. doi: 10.1310/hct1201-24.

Reference Type DERIVED
PMID: 21388938 (View on PubMed)

Funderburg N, Kalinowska M, Eason J, Goodrich J, Heera J, Mayer H, Rajicic N, Valdez H, Lederman MM. Effects of maraviroc and efavirenz on markers of immune activation and inflammation and associations with CD4+ cell rises in HIV-infected patients. PLoS One. 2010 Oct 6;5(10):e13188. doi: 10.1371/journal.pone.0013188.

Reference Type DERIVED
PMID: 20949133 (View on PubMed)

Cooper DA, Heera J, Goodrich J, Tawadrous M, Saag M, Dejesus E, Clumeck N, Walmsley S, Ting N, Coakley E, Reeves JD, Reyes-Teran G, Westby M, Van Der Ryst E, Ive P, Mohapi L, Mingrone H, Horban A, Hackman F, Sullivan J, Mayer H. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis. 2010 Mar 15;201(6):803-13. doi: 10.1086/650697.

Reference Type DERIVED
PMID: 20151839 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001026&StudyName=Trial%20of%20Maraviroc%20%28UK-427%2C857%29%20in%20Combination%20with%20Zidovudine/Lamivudine%20versus%20Efavirenz%20in%20Combination%20with%20Zidovudine/Lamivudine

To obtain contact information for a study center near you, click here.

Other Identifiers

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A4001026

Identifier Type: -

Identifier Source: org_study_id