Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With Ccr5 Tropic HIV 1 - Full Text View

Purpose

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

Condition	Intervention	Phase
HIV-1	Drug: Maraviroc Drug: Emtricitabine/tenofovir	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir +Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naïve HIV Infected Patients With Ccr5 Tropic HIV 1

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Ritonavir Tenofovir Disoproxil Fumarate Darunavir Maraviroc Darunavir ethanolate Truvada

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

The proportion of subjects with plasma HIV 1 RNA <50 copies/mL at Week 48. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: Frequency, severity and relationship of adverse events to test drug; serious adverse events; discontinuations due to adverse events; and frequency and severity of abnormal laboratory values. [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
The relationship between the proportion of patients with plasma HIV 1 RNA <50 copies/mL at the Week 48 and Week 96 visits and the screening tropism test (Genotype test or Enhanced Sensitivity Trofile Assay [ESTA]). [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
Virologic Response: Proportion of patients with plasma HIV RNA <50 copies/mL at Week 96. [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
Immunological Response at Week 48 and Week 96: a.Changes in CD4+ T lymphocyte (CD4) cell counts and percent change from Baseline; b.Changes in CD8+ T lymphocyte (CD8) cell counts and percent change from Baseline; c.Changes in CD4+/CD8+ ratio and [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
changes from Baseline. [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
Evolution of viral resistance and tropism change between Screening or Baseline and the time of confirmation of virologic failure or the last on treatment time point: a.HIV 1 tropism (Genotype test) b.For virologic failure with R5 virus, viral [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
resistance to maraviroc (maraviroc treated patients only). c.Viral resistance (Genotype and Phenotype) to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) and non nucleoside reverse transcriptase inhibitors (NNRTI) [reverse transcriptase [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
inhibitors, RTI] and protease inhibitors (PI). [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
Changes in peripheral fat distribution and trunk to limb fat ratio (using Dual Energy X-ray Absorptiometry [DEXA] scan) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm). [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
Changes in bone mineral density (using DEXA scan and serum markers) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm). [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	804
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Maraviroc Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.	Drug: Maraviroc Maraviroc tablet 150 mg once daily for 96 weeks. Other Name: Selzentry, Celsentri
Active Comparator: Emtricitabine/tenofovir Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.	Drug: Emtricitabine/tenofovir Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks. Other Name: Truvada

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit.
CD4 count equal to or greater than 100 cells/mm3 at Screening.
Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.

Exclusion Criteria:

Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.
CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345630

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 168 Study Locations

Sponsors and Collaborators

ViiV Healthcare

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT01345630 History of Changes
Other Study ID Numbers:	A4001095
Study First Received:	April 27, 2011
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:

Double-blind
comparative
trial
maraviroc
versus
emtricitabine/tenofovir

both with darunavir/ritonavir
antiretroviral-naive
Ccr5 tropic
Hiv 1
patients.

Additional relevant MeSH terms:

Ritonavir
Darunavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013

Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With Ccr5 Tropic HIV 1 (MODERN)