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

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Treatments: Abacavir; Dolutegravir; Emtricitabine; Lamivudine; Reverse Transcriptase Inhibitors; Tenofovir

Criteria

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.