CLINICAL TRIALS PROFILE FOR PIFELTRO
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All Clinical Trials for PIFELTRO
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03886701 ↗ | Doravirine, Rifapentine and Isoniazid Interaction | Completed | Merck Sharp & Dohme Corp. | Phase 1 | 2019-04-22 | Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs. |
| NCT03886701 ↗ | Doravirine, Rifapentine and Isoniazid Interaction | Completed | Walter K. Kraft | Phase 1 | 2019-04-22 | Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs. |
| NCT03894124 ↗ | Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers | Completed | Imperial College London | Phase 1 | 2019-06-12 | Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers |
| NCT03894124 ↗ | Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers | Completed | Merck Sharp & Dohme Corp. | Phase 1 | 2019-06-12 | Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers |
| NCT03894124 ↗ | Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers | Completed | University of Liverpool | Phase 1 | 2019-06-12 | Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers |
| NCT03894124 ↗ | Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers | Completed | Chelsea and Westminster NHS Foundation Trust | Phase 1 | 2019-06-12 | Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers |
| NCT04689737 ↗ | Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD) | Completed | Merck Sharp & Dohme Corp. | Phase 4 | 2021-03-20 | Doravirine is a novel non-nucleoside reverse transcriptase inhibitor that has demonstrated good efficacy, tolerability, and safety for the treatment of patients with HIV infection in phase III clinical trials. Doravirine achieved non- inferiority when compared with efavirenz- and darunavir/ritonavir-based regimens. Doravirine is mainly metabolized and eliminated by the liver, with only 6% of the drug being excreted unchanged through the urine.In a study comparing 8 subjects with severe renal disease to 8 subjects without renal impairment, the single dose exposure of doravirine was 43% higher in subjects with severe renal function impairment.However, according to prescribing information, no dosage adjustment of doravirine is required in patients with mild, moderate, or severe renal impairment. On the other hand, data on doravirine pharmacokinetics in patients with ESRD on dialysis are lacking. This may be of special interest because doravirine has a relatively low molecular weight and it is only 76% bound to proteins in plasma. These characteristics could make possible for hemodialysis to remove doravirine from plasma, potentially leading to subtherapeutic concentrations of doravirine after the dialysis sessions. On the contrary, doravirine volume of distribution is about 60 liters,15 what could limit extraction of doravirine by hemodialysis. Since data on doravirine pharmacokinetics in PLWH with ESRD on dialysis are lacking, our aim is to evaluate the effect of intermittent hemodialysis on doravirine concentrations in HIV-infected patients with ESRD |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for PIFELTRO
Condition Name
| Condition Name for PIFELTRO | |
| Intervention | Trials |
| Human Immunodeficiency Virus | 2 |
| Drug Interaction Potentiation | 1 |
| HIV-1-infection | 1 |
| HIV-infected Participants With ESRD Undergoing Routine Hemodialysis | 1 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for PIFELTRO
Trials by Country
Clinical Trial Progress for PIFELTRO
Clinical Trial Phase
Clinical Trial Sponsors for PIFELTRO
Sponsor Name
| Sponsor Name for PIFELTRO | |
| Sponsor | Trials |
| Merck Sharp & Dohme Corp. | 3 |
| Chelsea and Westminster NHS Foundation Trust | 2 |
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | 1 |
| [disabled in preview] | 3 |
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