HIV-1Phase 3MERITNCT00098293

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

A Phase 3 study testing Maraviroc + Zidovudine/Lamivudine, Efavirenz + Zidovudine/Lamivudine and Maraviroc (UK-427,857) + Zidovudine/Lamivudine in people with HIV-1, run by ViiV Healthcare at 144 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: HIV-1
What is being tested?: Maraviroc + Zidovudine/Lamivudine, Efavirenz + Zidovudine/Lamivudine and Maraviroc (UK-427,857) + Zidovudine/Lamivudine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 916 participants
Where: 144 sitesin 14 countries
Study dates: Nov 2004to Dec 2012
Phase: Phase 3
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

144 sites in 14 countries.

Country

City, postcode or hospital

144 sites in 14 countries

United States46 sites

Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Annandale, Virginia, 22003
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Beverly Hills, California, 90211
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35294-2050
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Boston, Massachusetts, 02118-2393
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Brooklyn, New York, 11203
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0405
Pfizer Investigational Site
Columbia, South Carolina, 29206
Pfizer Investigational Site
Dallas, Texas, 75208
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Flushing, New York, 11355
Pfizer Investigational Site
Houston, Texas, 77006
Pfizer Investigational Site
Houston, Texas, 77098
Pfizer Investigational Site
Huntersville, North Carolina, 28078
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Jacksonville, Florida, 32209
Pfizer Investigational Site
Los Angeles, California, 90022
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Los Angeles, California, 90069
Pfizer Investigational Site
Manhasset, New York, 11030
Pfizer Investigational Site
Miami, Florida, 33133
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Miami Beach, Florida, 33139
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Newport Beach, California, 92663
Pfizer Investigational Site
Oakland, California, 94602
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104-5068
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Omaha, Nebraska, 68106
Pfizer Investigational Site
Orlando, Florida, 32803
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Puyallup, Washington, 98372
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
San Francisco, California, 94115-3029
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
Sarasota, Florida, 34243
Pfizer Investigational Site
Springfield, Massachusetts, 01107
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tampa, Florida, 33614

Other trials in United States

Canada21 sites

Pfizer Investigational Site
Calgary, Alberta, T2R0X7
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7
Pfizer Investigational Site
Edmonton, Alberta, T6G 2C8
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Hamilton, Ontario, L8N 3Z5
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
Montreal, Quebec, H2L 4P9
Pfizer Investigational Site
Montreal, Quebec, H2L 5B1
Pfizer Investigational Site
Montreal, Quebec, H2W 1T8
Pfizer Investigational Site
Montreal, Quebec, H2X 2P4
Pfizer Investigational Site
Montreal, Quebec, H3G 1A4
Pfizer Investigational Site
Ottawa, Ontario, K1H 8L6
Pfizer Investigational Site
Sainte-Foy, Quebec, G1V 4G2
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, M5B 1W8
Pfizer Investigational Site
Toronto, Ontario, M5G 2N2
Pfizer Investigational Site
Vancouver, British Columbia, V6B 1R3
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 1Y6
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2C7
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2T1
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

South Africa14 sites

Pfizer Investigational Site
Bloemfontein, Free State, 9300
Pfizer Investigational Site
Bloomfontein
Pfizer Investigational Site
Cape Town, 7405
Pfizer Investigational Site
Cape Town, 7550
Pfizer Investigational Site
Cape Town, 7705
Pfizer Investigational Site
Cape Town, 7780
Pfizer Investigational Site
Dundee, KwaZulu-Natal, 3000
Pfizer Investigational Site
Johannesburg, Gauteng, 2092
Pfizer Investigational Site
Johannesburg, 2047
Pfizer Investigational Site
Port Elizabeth, Eastern Cape, 6065
Pfizer Investigational Site
Pretoria, Gauteng, 0083
Pfizer Investigational Site
Pretoria, 0132
Pfizer Investigational Site
Pretoria North, 0182
Pfizer Investigational Site
Soweto, Johannesburg, 2013

Other trials in South Africa

Australia9 sites

Pfizer Investigational Site
Burwood, New South Wales, 2134
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010
Pfizer Investigational Site
Fitzroy North, Victoria, 3068
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Melbourne, Victoria, 3004
Pfizer Investigational Site
Miami, Queensland, 4220
Pfizer Investigational Site
South Yarra, Victoria, 3141
Pfizer Investigational Site
Surrey Hills, New South Wales, 2010
Pfizer Investigational Site
Wentworthville, New South Wales, 2145

Other trials in Australia

United Kingdom9 sites

Pfizer Investigational Site
Birmingham, B9 5SS
Pfizer Investigational Site
Brighton, BN2 1ES
Pfizer Investigational Site
Edinburgh, Loth, ED4 2XU
Pfizer Investigational Site
Edinburgh, EH4 2XU
Pfizer Investigational Site
London, NW3 2QG
Pfizer Investigational Site
London, SE5 9RS
Pfizer Investigational Site
London, SW10 9NH
Pfizer Investigational Site
London, W2 1NY
Pfizer Investigational Site
Manchester, M8 5RB

Other trials in United Kingdom

Argentina8 sites

Pfizer Investigational Site
Buenos Aires
Pfizer Investigational Site
Ciudad de Buenos, C1282AEN
Pfizer Investigational Site
Ciudad de Buenos Aires, C1202ABB
Pfizer Investigational Site
Ciudad de Buenos Aires, C1406FWY
Pfizer Investigational Site
El Palomar, Buenos Aires, 1684
Pfizer Investigational Site
Neuquén, Neuquén Province, Q8300PMB
Pfizer Investigational Site
Provincia de Buenos Aires
Pfizer Investigational Site
Provincia de Santa Fe

Other trials in Argentina

Italy7 sites

Pfizer Investigational Site
Antella (FI), 50011
Pfizer Investigational Site
Brescia, 25123
Pfizer Investigational Site
Milan, 20127
Pfizer Investigational Site
Modena, 41100
Pfizer Investigational Site
Roma, 00161
Pfizer Investigational Site
Roma, 00185
Pfizer Investigational Site
Torino, 10149

Other trials in Italy

Poland7 sites

Pfizer Investigational Site
Bialystok, 15-540
Pfizer Investigational Site
Bydgoszcz, 85-030
Pfizer Investigational Site
Chorzów, 41-500
Pfizer Investigational Site
Gdansk, 80-214
Pfizer Investigational Site
Krakow, 31-531
Pfizer Investigational Site
Szczecin, 71-455
Pfizer Investigational Site
Warsaw, 01-201

Other trials in Poland

Switzerland7 sites

Pfizer Investigational Site
Basel, 4031
Pfizer Investigational Site
Bern, 3010
Pfizer Investigational Site
Geneva, 1211
Pfizer Investigational Site
Lugano, 6900
Pfizer Investigational Site
Sankt Gallen, 9007
Pfizer Investigational Site
Zurich, 8038
Pfizer Investigational Site
Zurich, 8091

Other trials in Switzerland

Belgium4 sites

Pfizer Investigational Site
Brussels, 1000
Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, B-3000 Leuven

Other trials in Belgium

Mexico4 sites

Pfizer Investigational Site
Del. Tlalpan C.P., Mexico City, 14050
Pfizer Investigational Site
Del. Tlalpan, C.P., Mexico City, 14000
Pfizer Investigational Site
Del. Tlalpan, C.P., Mexico City, 14080
Pfizer Investigational Site
Delegacion Tlalpan C. P, Mexico City, 14080

Other trials in Mexico

Puerto Rico4 sites

Pfizer Investigational Site
Ponce, 00731
Pfizer Investigational Site
Rio Piedras, 00935
Pfizer Investigational Site
San Juan, 00909
Pfizer Investigational Site
San Juan, 00935

Other trials in Puerto Rico

Netherlands3 sites

Pfizer Investigational Site
Amsterdam, 1091 AC
Pfizer Investigational Site
Rotterdam, 3015 GD
Pfizer Investigational Site
Utrecht, 3584 CX

Other trials in Netherlands

Brazil1 site

Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20210-030

Other trials in Brazil

About this 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

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.

Conditions: HIV-1
Being tested: Maraviroc + Zidovudine/Lamivudine, Efavirenz + Zidovudine/Lamivudine, Maraviroc (UK-427,857) + Zidovudine/Lamivudine
Keywords: Aids, HIV
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Maraviroc + Zidovudine/LamivudineDrug
maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
Efavirenz + Zidovudine/LamivudineDrug
efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)
Maraviroc (UK-427,857) + Zidovudine/LamivudineDrug
maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)

Study groups in NCT00098293
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Maraviroc + Zidovudine/Lamivudine
3	Active comparator	Not described Receives: Drug: Efavirenz + Zidovudine/Lamivudine
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 Receives: Drug: Maraviroc (UK-427,857) + Zidovudine/Lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population
Measured: Week 48
Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population
Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.
Measured: Week 48

Secondary outcomes (13)

Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression
Measured: Week 48
Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression
Measured: Week 96
Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Measured: Baseline, Week 48, Week 96
Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels
TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.
Measured: Baseline up to Week 48 and Week 96
Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96
Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.
Measured: Baseline, Week 48, Week 96
Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96
Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.
Measured: Baseline, Week 48, Week 96
Time to Virologic Failure
Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.
Measured: Week 48, Week 96
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment.
Measured: Baseline, time of failure through Week 48
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96
Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment.
Measured: Baseline, time of failure through Week 96
Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96
Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized.
Measured: Screening, time of failure through Week 48, Week 96
Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96
Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations.
Measured: Screening, time of failure through Week 48, Week 96
Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96
Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L).
Measured: Screening, time of failure through Week 48, Week 96
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening
Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.
Measured: Baseline, Week 48, Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004Dec 2012

First posted7 Dec 2004 (estimated)
Study startNov 2004
Primary completionApr 2007
Study completionDec 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 (4)Papers the sponsor has linked to this study.
Other trials for HIV-1Studies of the same condition, open and under way.
More trials run by ViiV HealthcareThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 916 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00098293
Sponsor's protocol ID: A4001026
Acronym: MERIT
Status last verified: Aug 2013
First submitted: 6 Dec 2004
Last updated: 9 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30192390
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.
PubMed 21388938
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.
PubMed 20949133
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.
PubMed 20151839

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00098293
Acronym / sponsor ID: MERIT / A4001026
Conditions: HIV-1
Keywords: Aids, HIV
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 916 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Nov 2004
Primary completion: Apr 2007 (actual)
Study completion: Dec 2012 (actual)
First posted: 7 Dec 2004 (estimated)
Results: Posted 5 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Maraviroc + Zidovudine/Lamivudine
3	Active comparator	Drug: Efavirenz + Zidovudine/Lamivudine
2	Experimental	Drug: Maraviroc (UK-427,857) + Zidovudine/LamivudineFollowing 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

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (16 listed)

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

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
Maraviroc + Zidovudine/Lamivudinemaraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)	Drug	1
Efavirenz + Zidovudine/Lamivudineefavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)	Drug	3
Maraviroc (UK-427,857) + Zidovudine/Lamivudinemaraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)	Drug	2

Primary outcome

Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population
Time frame: Week 48
Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population
Time frame: Week 48
Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.

13 secondary outcomes

Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression
Time frame: Week 48
Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression
Time frame: Week 96
Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96
Time frame: Baseline, Week 48, Week 96
Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels
Time frame: Baseline up to Week 48 and Week 96
Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96
Time frame: Baseline, Week 48, Week 96
Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96
Time frame: Baseline, Week 48, Week 96
Time to Virologic Failure
Time frame: Week 48, Week 96
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Time frame: Baseline, time of failure through Week 48
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96
Time frame: Baseline, time of failure through Week 96
Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96
Time frame: Screening, time of failure through Week 48, Week 96
Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96
Time frame: Screening, time of failure through Week 48, Week 96
Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96
Time frame: Screening, time of failure through Week 48, Week 96
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening
Time frame: Baseline, Week 48, Week 96

Results and safety

Results posted to the registry on 5 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maraviroc Once Daily + CBV (DB)	177	0
Maraviroc Twice Daily + CBV (DB and OL)	368	202
Efavirenz Once Daily + CBV (DB and OL)	372	202
Maraviroc Twice Daily + CBV (OL)	0	0
Maraviroc Twice Daily + CBV (SP)	0	0

Primary outcome: Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population

Time frame: Week 48. Number. Unit: Percentage of participants

Measure	Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) n = 174	Maraviroc Twice Daily + CBV (DB) n = 360	Efavirenz Once Daily + CBV (DB) n = 361
Less than 400 copies/mL	61.5	70.6	73.1
Less than 50 copies/mL	55.8	65.3	69.3

Maraviroc Twice Daily + CBV (DB) vs Efavirenz Once Daily + CBV (DB): Difference in Percentage: -3.0
Maraviroc Twice Daily + CBV (DB) vs Efavirenz Once Daily + CBV (DB): Difference in Percentage: -4.2

Population analysed: FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).

Primary outcome: Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population

Time frame: Week 48. Number. Unit: Percentage of participants

Measure	Maraviroc Twice Daily + CBV (DB) n = 360	Efavirenz Once Daily + CBV (DB) n = 361
Less than 400 copies/mL	75.00	78.27
Less than 50 copies/mL	70.00	74.44

Maraviroc Twice Daily + CBV (DB) vs Efavirenz Once Daily + CBV (DB): Difference in Percentage: -4.1
Maraviroc Twice Daily + CBV (DB) vs Efavirenz Once Daily + CBV (DB): Difference in Percentage: -4.4

Population analysed: Per protocol (PP) population included all randomized participants who had taken at least 1 dose of study medication, were treated for at least 14 days or discontinued before this time due to treatment failure, were \>80% compliant with randomized treatment and had no violation of any inclusion or exclusion criteria, which affected efficacy. MD=F.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)	47 of 174 (27%)	151 of 174 (86.8%)	Not reported
Maraviroc Twice Daily + CBV (DB and OL)	77 of 360 (21.4%)	319 of 360 (88.6%)	Not reported
Efavirenz Once Daily + CBV (DB and OL)	82 of 361 (22.7%)	327 of 361 (90.6%)	Not reported
Maraviroc Twice Daily + CBV (SP)	4 of 127 (3.1%)	0 of 127 (0%)	Not reported

Limitations and caveats (from the sponsor): Following DSMB decision to discontinue maraviroc 300 mg once daily, inferential statistical analyses was performed between maraviroc 300 mg twice daily and efavirenz 600 mg once daily only. Data at Week 24 was not analyzed as planned in protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30192390Vourvahis 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.
Derived from this study: PubMed 21388938MacInnes 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.
Derived from this study: PubMed 20949133Funderburg 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.
Derived from this study: PubMed 20151839Cooper 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

144 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 16 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 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Canada, South Africa, Australia, United Kingdom and 9 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Oct 2012). 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?

Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population (time frame: Week 48). The study lists 2 primary outcomes in all. 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 NCT00098293, which also lists 4 linked publications.

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 9 Oct 2013; AzTrials last refreshed its copy on 8 Nov 2026.