Status:
COMPLETED
Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Janssen-Cilag Tibotec
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant vir...
Detailed Description
Methods: A phase II pilot, prospective, open label, single arm multicentric clinical trial assessing a darunavir/ritonavir, etravirine and MK-0518-containing regimen, if possible associated to an opti...
Eligibility Criteria
Inclusion
- Age: 18 years and above
- Documented HIV-1 infection.
- History of virological failure on NNRTIs (patients with a history of toxicity to nevirapine and efavirenz may be enrolled in this study).
- On a combination antiretroviral therapy for at least 8 weeks prior to the screening visit (if on tipranavir, or enfuvirtide these drugs should have been introduced more than 8 weeks before the screening visit).
- Patient naive to darunavir, etravirine and to integrase inhibitors
- Plasma viral load at screening visit over 1000 copies/ml, (no CD4 restriction).
- Genotypic resistance testing at the screening visit:
- Protease inhibitor mutations: over or equal to 3 primary protease inhibitor mutations among: D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, I54M, L76V, V82A/F/L/T/S, I84V, N88S and L90M (IAS list 2006) but below or equal to 3 mutations among the following: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, L76V, I84V et L89V (virus sensitivity to darunavir/ritonavir).
- Reverse transcriptase mutations: over or equal to 3 NRTI mutations (among IAS list) and below or equal to 3 mutations among: A98G, L100I, K101Q/P/E, K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179D/E/F/G/I, Y181C/I/V/C/H/L, Y188C/H/L, G190A/C/E/Q/S, P225H, F227C/L, M230I/L, P236L, K238N/T and Y318F (virus sensitivity to etravirine)
Exclusion
- Non effective barrier contraception in women of child bearing potential
- Pregnant women or women who are breastfeeding
- Opportunistic infection at the acute phase
- Decompensated cirrhosis (stage B or C of Child-Pugh score)
- Malignancy requiring chemotherapy or radiotherapy
- Contraindicated medications being taken by the patient (listed in protocol)
- Allergy to the active substances and expedients of darunavir, etravirine and raltegravir.
- Haemoglobin \< 7g/dl, neutrophil cell count \< 500/mm3, platelets \< 50,000/mm3, creatinine clearance \< 50 ml/mn, P. alkaline, AST, ALT or total bilirubin over or equal to 3 times normal values.
- Patients receiving experimental agents with an exclusion period for participation in other studies applicable at the screening visit of the current study.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00460382
Start Date
May 1 2007
End Date
September 1 2009
Last Update
September 17 2010
Active Locations (1)
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1
Hôpital Gustave Dron, Service Maladies Infectieuses
Tourcoing, France, 59208