HIV, HIV Infections
Conditions
Keywords
Switching, Maraviroc, Virological efficacy, Lipid profile, Tropism
Brief summary
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.
Detailed description
This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial. Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz). Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach. The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.
Interventions
DRUGmaraviroc
HAART regimen including 2 NRTI/NtRTIs plus maraviroc
DRUGcontrol group
HAART regimen including 2 NRTI/NtRTIs plus one of the following : * 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) * or ATV/unboosted (in a regimen without tenofovir) * or 1 NNRTI (nevirapine or efavirenz).
Sponsors
Germans Trias i Pujol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV-1 infected adults (=/+18 years old). 2. Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI. 3. Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) while on HAART. 4. Patient having at least one of the following conditions: * Antiretroviral-related gastrointestinal disturbances, or * Low patient's satisfaction associated with the current regimen posology (ritonavir use, ritonavir intolerance…), or * Any toxicity drug related. 5. Nadir CD4 cell count \> 350 cells/mm3. 6. Absence of resistance mutations in the RT or PR by (TrugeneTM) 7. Good treatment adherence. 8. Voluntary written informed consent.
Exclusion criteria
1. Virologic failure to a previous antiretroviral regimen. 2. Any antiretroviral resistance mutation in a previous resistance test. 3. Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch. 4. Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion. 5. Pregnancy or fertile women willing to be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral load | 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Administration of lipid-lowering drugs | 48 weeks | — |
| Changes in the SCORE equation | 48 weeks | — |
| CD4 / CD8 cell counts | 48 weeks | — |
| Antiretroviral resistance and viral tropism | 48 weeks | — |
| Time to virological failure | 48 weeks | — |
| Total cholesterol | 48 weeks | Total cholesterol levels |
| HDL-cholesterol | 48 weeks | HDL-cholesterol levels |
| LDL-cholesterol | 48 weeks | LDL-cholesterol levels |
| Triglyceride | 48 weeks | Triglyceride levels |
| Patients who withdraw | 48 weeks | — |
Countries
Spain
Outcome results
None listed