EUCTR2012-003501-10-ES
Active, not recruiting
Phase 1
Efficacy of dual antiretroviral treatment with maraviroc plus ritonavir-boosted darunavir in early rescue therapy in patients with HIV-1 infection: pilot, multicenter, randomized, controlled and open phase II clinical trial. BIMARTHE study - Bimarthe
Vall d'Hebron Institut de Recerca (VHIR)0 sites90 target enrollmentJanuary 9, 2013
ConditionsAdult patients with HIV-1 infection that present virologic failure to first-line antiretroviral treatment.MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adult patients with HIV-1 infection that present virologic failure to first-line antiretroviral treatment.
- Sponsor
- Vall d'Hebron Institut de Recerca (VHIR)
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Adult patients with HIV\-1 infection
- •\- Virologic failure, definded as two consecutive HIV RNA levels \> 400 cop/ml within 2\-6 weeks, when being under stable ART for at least 3 months
- •\- Genotipic resistance to lamivudine/emtricitabine (M184V/I) irrespective of other NRTIs or NNRTIs associated mutations. Patients with current or previous virologic failure to an IP/r based regimen may be included if the number of IPs associated mutations is ? 2 and there are no IPs primary resistances or DRV associated mutations
- •\- CCR5 viral tropism determined by V3 sequencing. The period between the determination of viral tropism and inclusion in the study will be 6 weeks maximum
- •\- Informed consent
- •\- Women without reproductive potential and not breastfeeding.
- •\- Women with reproductive potential if they are not breastfeeding and who meet the following criteria:
- •\* Negative pregnancy test at baseline
- •\* Accept commit to avoid pregnancy until 30 days after the last dose of study drug, by using double barrier method of contraception or abstinence.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •\- AIDS defining event within 48 weeks before starting study
- •\- Current HIV RNA load \> 100\.000 cop/ml
- •\- Current CD4\+ cell count \< 100 cel/mm³
- •\- HBV coinfection (HBsAg positive)
- •\- Descompensated liver cirrhosis (Child\-Pugh B/C)
- •\- Chronic renal failure (Clearance of creatinine MDRD \< 30 ml/min/1,73m2\)
- •\- Patients unable to understant the study prtocol or candidates who, in researcher opinion, are not appropiate to be enroled in the study
- •\- Pregnant, lactating or with reproductive potential women, who not commit to avoid pregnancy until 30 days after the last dose of study drug.
Outcomes
Primary Outcomes
Not specified
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