Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Completed; Phase 4

Conditions: HIV-1-infection; Solid Organ Transplant

Treatments: Drug: Dolutegravir 50 mg; Drug: Abacavir 600 MG; Drug: Emtricitabine 200 MG; Drug: Tenofovir Disoproxil 245Mg Tablet; Drug: Lamivudine 300 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03360682

DTG-SOT

2017-000469-62 (EudraCT Number)

Details and patient eligibility

About

The aims of this study are to obtain pharmacokinetic data on interactions between dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and Mycophenolic acid) in solid organ transplant (SOT) recipients to provide proof of principle data that DTG plus 2 nucleosides (NUCs) is safe and effective in HIV-infected SOT recipients.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 antiretroviral therapy (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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

HIV-1-infected solid organ transplant patients 1

Experimental group

Description:

The patient or donor is not a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is not a carrier of the hepatitis B virus. treatment 48 weeks

Treatment:

Drug: Lamivudine 300 MG

Drug: Abacavir 600 MG

Drug: Dolutegravir 50 mg

HIV-1-infected solid organ transplant patients 2

Experimental group

Description:

The patient or donor is a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is a carrier of the hepatitis B virus. treatment 48 weeks

Treatment:

Drug: Tenofovir Disoproxil 245Mg Tablet

Drug: Emtricitabine 200 MG

Drug: Dolutegravir 50 mg