Pilot single-arm clinical trial to evaluate the efficacy, PK interactions and safety of dolutegravir plus 2 NRTIs in HIV-1-infected solid organ transplant patients. DGT-SOT

Phase 1

• Conditions: HIV-1 infected solid organ transplant patients; MedDRA version: 20.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; MedDRA version: 20.0Level: PTClassification code 10057925Term: Transplant evaluationSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-000469-62-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-16
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.HIV patients >18 years old who provide signed and dated informed consent;
2.Males and females;
3.SOT recipients (heart, liver or kidney);
4.On stable ART for =6 months preceding the screening visit;
5.Plasma HIV RNA <50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load >50 between determinations);
6.Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.HIV patients who have stopped ART due to virological failure;
2.HIV patients who require treatment with DTG contraindicated medications;
3.History or presence of an allergy or intolerance to the study drug;
4.Active opportunistic infection;
5.Neoplasms requiring chemotherapy.
6.Pregnancy or breast feeding or planned pregnancy during the study period
7.Any other contraindication to study drugs.

Study & Design

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