Maraviroc (Celsentri) With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients (TERCETO)
Recruitment status was: Recruiting
Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects.
The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48 weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.
|HIV-1 Adults Patients AIDS Triple Class Failure||Drug: maraviroc Drug: Raltegravir Drug: Darunavir/ritonavir||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 4, Single Arm, Open Label, Pilot Study of Maraviroc (Celsentri) in Combination With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients.|
- Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24 [ Time Frame: week 24 ]
- Proportion of patients with HIV RNA levels of less than 50 copies/ml at week 24 and with HIV RNA levels of less than 400 copies/ ml at weeks 24 and 48. [ Time Frame: week 24 and week 48 ]
|Study Start Date:||February 2010|
- darunavir : two 300 mg pills twice daily with meal
- ritonavir: one 100 mg pill twice daily with meal
This is a Phase 4, single arm, open-label, study designed to demonstrate the safety, tolerability, efficacy, antiviral and immunological activity of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir in patients with limited to no treatment option in HIV-1 infected subjects ≥ 21 years old.
The trial population will comprise 60 HIV-infected subjects with history of triple class antiretroviral failure, naïve to CCR5-inhibitors, integrase-inhibitors and darunavir will be evaluated. Single arm, stratified according to plasma viral load at screening (> or < 100,000 copies/ml).
Those with evidence of R5 viruses and susceptibility to darunavir in the resistance testing analysis, plus history of failure to NRTIs, NNRTIs and at least one PI, plus a genotype analysis showing evidence of resistance to NRTIs (at least 2 TAMS and/or Q151M and or 69ss), resistance to PIs (at least 2 major mutations), will start a regimen of maraviroc, raltegravir and ritonavir boosted darunavir.
This trial will consist of a screening period of up to 6 weeks, a 48-week treatment period, with interim analysis at 16 and 24 weeks. Followed by a 4-week post-treatment follow-up (FU) period.
Virologic response, CD4 count change, clinical outcomes and safety will be followed throughout the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013987
|Contact: Alejandro Krolewiecki, MD||54-11-4981-7777 ext firstname.lastname@example.org|
|Ciudad de Buenos Aires, Argentina, C1202ABB|
|Contact: María C. Magneres, MD 54-11-4981-7777 ext 114 email@example.com|
|Contact: Patricia Luz Patterson, MD 54-11-4981-7777 ext 114 firstname.lastname@example.org|
|Principal Investigator: Alejandro Krolewiecki, MD|