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Switch to Darunavir/r + Maraviroc QD in Patients With R5 Tropism by Viral DNA Genotyping (GUSTA)

This study is currently recruiting participants.
Verified June 2011 by Catholic University of the Sacred Heart
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01367210
First received: June 3, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

Objectives of the study:

  1. To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.
  2. To collect relevant information about the safety, the immunologic and the economic impact of this strategy.

Condition Intervention Phase
HIV Infection
 Drug: Maraviroc, Darunavir/r
Drug: current antiretroviral therapy with 3 drugs
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switch to Darunavir/r + Maraviroc QD in Patients With R5 Tropism by Viral DNA Genotyping With Suppressed Viremia (GUSTA): a Multicenter, Open-label, Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 96 weeks at intention-to treat analysis with missing value=Failure [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to virological failure at survival analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with at failure X4 tropism viral tropism (RNA or DNA genotyping) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Evolution of CD4 cell count during the 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Evolution of adherence and quality of life after 24, 48 and 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Evolution of maraviroc plasma concentrations during the 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Evolution of metabolic parameters at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Change of the results of neurocognitive tests at 48 and 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Modification of bone density and subcutaneous fat at 48 and 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Modification of IMT and FMD at 48 and 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Economic impact of DRV/r+ MVC versus CAT [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: June 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MARAVIROC, DARUNAVIR/r
Treatment simplification from a "standard" combined antiretroviral therapy including 3 drugs to Maraviroc plus Darunavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy
 Drug: Maraviroc, Darunavir/r
Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg
Sham Comparator: current ART with 3 drugs
Patients on HAART with three drugs and HIV RNA below 50 copies/mL
 Drug: current antiretroviral therapy with 3 drugs
To continue the assumption of previous HAART

  Eligibility

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

Inclusion Criteria:

  • Patients treated with the same regimen including 3 HAART from at least 4 months
  • Aged 18 years or older
  • Who gave informed consent to the participation to the study
  • With at least two viral load < 50 copies/mL in two consecutive determinations at least 6 months apart (tolerance of two weeks)
  • With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease for at least one year prior to the screening.
  • With R5 tropism by viral DNA genotyping (geno2pheno "clonal")

Exclusion Criteria:

  • With at least one major or two minor mutation conferring resistance to darunavir reported in the update list of International AIDS Society - USA , in previous resistance test
  • Previous D/M or X4 viral tropism
  • Previous major clinical toxicities (grade >=3) to the proposed drugs of the study
  • Pregnancy or breast feeding, desire of pregnancy in the short term
  • Past exposure to CCR5 antagonist
  • HBsAg serostatus
  • Liver cirrhosis of class C (Child-Pugh)
  • Sulpha drug hypersensitivity
  • The presence of major non AIDS-defining diseases that, in the opinion of the investigator, may compromise the retention of the patient in the study for the necessary follow-up period.
  • Estimated glomerular filtration < 30 ml/min (Cockroft-Gaut; MDRD if black-African or african-american) at screening visit
  • Hypertransaminemia of grade IV (more than 10 times the upper normal limit) at screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367210

Contacts
Contact: Andrea De Luca, Prof 00390630154945 andrea.deluca@rm.unicatt.it
Contact: Manuela Colafigli, MD 00390630155366 manuela76@inwind.it

Locations
Italy
Catholic University of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Andrea De Luca, MD     00390630154945     andrea.deluca@rm.unicatt.it    
Sub-Investigator: Manuela Colafigli, MD            
Sub-Investigator: Massimiliano Fabbiani, MD            
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Andrea De Luca, Prof Catholic University of the Sacred Heart
  More Information

No publications provided

Responsible Party: Prof Andrea De Luca, Catholic University of the Sacred Heart, Rome, Italy
ClinicalTrials.gov Identifier: NCT01367210     History of Changes
Other Study ID Numbers: 2010-023316-13
Study First Received: June 3, 2011
Last Updated: June 3, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Catholic University of the Sacred Heart:
HIV
AIDS
HAART
Simplification
 Maraviroc
Darunavir
Treatment experienced
Tropism

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Darunavir
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

ClinicalTrials.gov processed this record on May 23, 2013