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

Phase 4

• Conditions: HIV-1-infection; Solid Organ Transplant
• Interventions: Drug: Lamivudine 300 MG; Drug: Abacavir 600 MG; Drug: Tenofovir Disoproxil 245Mg Tablet; Drug: Emtricitabine 200 MG; Drug: Dolutegravir 50 mg

• Registration Number: NCT03360682
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-04
• Study Start: 2018-04-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-07
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV-1-infected solid organ transplant patients 2	Emtricitabine 200 MG	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
HIV-1-infected solid organ transplant patients 1	Abacavir 600 MG	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
HIV-1-infected solid organ transplant patients 1	Dolutegravir 50 mg	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
HIV-1-infected solid organ transplant patients 1	Lamivudine 300 MG	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
HIV-1-infected solid organ transplant patients 2	Dolutegravir 50 mg	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
HIV-1-infected solid organ transplant patients 2	Tenofovir Disoproxil 245Mg Tablet	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic study	24-hours before the switch and 24-hours 2 weeks after switching	"Peak Plasma Concentration (Cmax) mg /mL of dolutegravir.

Secondary Outcome Measures

Name	Time	Method
Lipid profile	week 48	To assess the changes in lipid profile (triglycerides)
Renal function	week 48	To assess creatinine \>normal valors mg/dl\> 120 mg/dl
Viral resistance	week 48	number op patients with VIH viral load \> 50 copies/mL virological failure.
Safety: number AEs and SAEs	week 48	number AEs and SAEs
Changes in CD4+ cell	week 48	To assess the changes in CD4+ cell count \>200 cel/mL in peripheral blood.

Trial Locations

Locations (1)

Hospital Clínico y provincial de Barcelona; 🇪🇸 Barcelona, Spain