HIV Infections Clinical Trial
Official title:
Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) With Viral Suppression in Taiwan
Verified date | February 2020 |
Source | Yu-Jay Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) with Viral Suppression in Taiwan
Status | Completed |
Enrollment | 50 |
Est. completion date | July 16, 2019 |
Est. primary completion date | March 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients who are receiving co-formulated TDF/ FTC/ EFV (600 mg) and have achieved an undetectable plasma viral load (<50 copies/mL) for 6 months or longer at screening visit. - Having C12 EFV of 1 mg/L or greater at screening. - (C12 EFV will be determined by using blood sample collected 12 ± 1 hour after previous dosing of co-formulated TDF/ FTC/ EFV (600 mg). - No known treatment failure to regimens containing TDF, 3TC or FTC, plus EFV. - Infected with HIV harboring no known resistance-associated mutations to EFV, TDF, 3TC or FTC. - No known allergies to EFV, TDF, 3TC or FTC. - Aged ?20 years. - Calculated creatinine clearance (ClCr) = 50 mL/min (Cockcroft-Gault formula). - Provision of written informed consent. Exclusion Criteria: - The following laboratory values: - Absolute neutrophil count (ANC) <500 cells/µL - Hemoglobin <7.0 g/dL - Platelet count <50,000 cells/µL - Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >5x upper limit of normal (ULN) - Pregnant women or nursing mothers. - Active opportunistic or malignant disease not under adequate control. - Use of immunomodulators within 30 days prior to screening visit. - Use any of the prohibited medications: bepridil, astemizole, terfenadine, dihydroergotamine, ergometrine, ergotamine, systemic cytotoxic chemotherapy, amodiaquine, pimozide, midazolam, triazolam, cisapride?St John's Wort? Elbasvir/Grazoprevir and Simeprevir. |
Country | Name | City | State |
---|---|---|---|
Taiwan | E-Da Hospital | Kaohsiung | |
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Yu-Jay Corp. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C12 EFV concentration | The proportion of subjects achieving C12 EFV concentration >1.0 mg/L at Week 4. | Week 4 | |
Secondary | HIV-1 RNA load | The proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at Week 12 | Week 12 | |
Secondary | HIV-1 RNA load | The proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at Week 24 | Week 24 | |
Secondary | EFV concentration | The mean changes from baseline in C12 EFV concentration at Week 4. | Week 4 | |
Secondary | CD4+ T cell count | The mean changes from baseline in CD4+ T cell count at Week 12. | Week 12 | |
Secondary | CD4+ T cell count | The mean changes from baseline in CD4+ T cell count at Week 24. | Week 24 |
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