Antiretroviral treatment with maraviroc plus ritonavir-boosted darunavir for early salvage therapy

Phase 1

• Conditions: Adult 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 infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-003501-10-ES
• Lead Sponsor: Vall d'Hebron Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-09
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified