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

NCT ID: NCT01367210

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Maraviroc, Darunavir/r

Intervention Type: DRUG

Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg

current ART with 3 drugs

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

Group Type: SHAM_COMPARATOR

current antiretroviral therapy with 3 drugs

Intervention Type: DRUG

To continue the assumption of previous HAART

Interventions

Maraviroc, Darunavir/r

Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg

Intervention Type: DRUG

current antiretroviral therapy with 3 drugs

To continue the assumption of previous HAART

Intervention Type: DRUG

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

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Simona Di Giambenedetto

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea De Luca, Prof

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

Catholic University of Sacred Heart

Rome, , Italy

Countries

Italy

Other Identifiers

2010-023316-13

Identifier Type: -

Identifier Source: org_study_id