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

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Anti-Retroviral Agents; Darunavir; Maraviroc

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