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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03360682
• Other study ID #: DTG-SOT
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 12, 2018
• Est. completion date: January 2021

Study information

• Verified date: February 2020
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection
• Solid Organ Transplant

Intervention

Drug:
• Lamivudine 300 MG
Lamivudine 300 MG/day (48 weeks)
• Abacavir 600 MG
Abacavir 600 MG/day (48 weeks)
• Dolutegravir 50 mg
Dolutegravir 50 MG/day (48 weeks)
• Tenofovir Disoproxil 245Mg Tablet
Tenofovir 245 MG/day (48 weeks)
• Emtricitabine 200 MG
Emtricitabine 200 MG/day (48 weeks)

Locations

Country	Name	City	State
Spain	Hospital Clínico y provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic study	"Peak Plasma Concentration (Cmax) mg /mL of dolutegravir.	24-hours before the switch and 24-hours 2 weeks after switching
Secondary	Viral resistance	number op patients with VIH viral load > 50 copies/mL virological failure.	week 48
Secondary	Changes in CD4+ cell	To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood.	week 48
Secondary	Lipid profile	To assess the changes in lipid profile (triglycerides)	week 48
Secondary	Renal function	To assess creatinine >normal valors mg/dl> 120 mg/dl	week 48
Secondary	Safety: number AEs and SAEs	number AEs and SAEs	week 48