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

Catholic University of the Sacred Heart

Status and phase: Terminated; Phase 4

Conditions: HIV Infection

Treatments: Drug: current antiretroviral therapy with 3 drugs; Drug: Maraviroc, Darunavir/r

Study type: Interventional

Funder types: Other

Identifiers

NCT01367210

2010-023316-13

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

MARAVIROC, DARUNAVIR/r

Experimental group

Description:

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

Treatment:

Drug: Maraviroc, Darunavir/r

current ART with 3 drugs

Sham Comparator group

Description:

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

Treatment:

Drug: current antiretroviral therapy with 3 drugs