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

NCT01367210 | Terminated Phase 4

• 1 other identifier: 2010-023316-13
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives of the study:

1. 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. 2.To collect relevant information about the safety, the immunologic and the economic impact of this strategy.

Conditions

HIV Infection

Keywords

HIV; AIDS; Highly Active AntiRetroviral Therapy; Simplification; Maraviroc; Darunavir; Treatment experienced; Tropism

Outcome Measures

Primary Outcomes (1)

• 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

  48 weeks

Secondary Outcomes (11)

• 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

  96 weeks

• Time to virological failure at survival analysis

  48 weeks

• Proportion of patients with at failure X4 tropism viral tropism (RNA or DNA genotyping)

  48 weeks

• Evolution of CD4 cell- cluster of differentiation 4 cell count during the 96 weeks

  96 weeks

• Evolution of adherence and quality of life after 24, 48 and 96 weeks

  96 weeks

Study Arms (2)

MARAVIROC, DARUNAVIR/r

EXPERIMENTAL

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

current ART with 3 drugs

SHAM COMPARATOR

Patients on HAART with three drugs and HIV RNA below 50 copies/mL

Drug: current antiretroviral therapy with 3 drugs

Interventions

Maraviroc, Darunavir/r DRUG

Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg

MARAVIROC, DARUNAVIR/r

current antiretroviral therapy with 3 drugs DRUG

To continue the assumption of previous HAART

current ART with 3 drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")
• With CD4 cell count nadir\>50 cell/mmc or 100 cell/mmc if previous enfuvirtide or integrase inhibitors use

You may not qualify if:

• 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 Chemokine Receptor 5 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 formula if black-African or african-american) at screening visit
• Hypertransaminasemia of grade IV (more than 10 times the upper normal limit) at screening visit

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrea De Luca, Prof

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 7, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

IT (1)