Safety and Effectiveness of the Drug DPC 083 in Combination With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Patients Who Are Failing Treatment With Nonnucleoside Reverse Transcriptase Inhibitors
The purpose of this study is to determine the safety and tolerability of the study drug DPC 083 combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients who are failing their nonnucleoside reverse transcriptase inhibitor (NNRTI) treatment.
In some studies DPC 083 (an NNRTI) has been found to lower the amount of HIV in the blood (viral load), where drug-resistant types of HIV were not lowered by other NNRTIs. This study will attempt to determine how safe DPC 083 is when it is taken in combination with 2 NRTIs.
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Official Title:||A Phase II, Open Label, Multicenter Study to Assess the Safety and Efficacy of 100 Mg DPC 083 Once Daily in Combination With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Subjects Who Are Failing Treatment With a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Regimen|
Preclinical and human pharmacokinetic data suggest that DPC 083 can be administered once daily and provide trough plasma concentrations of free drug that will suppress replication of HIV-1, including strains containing key resistance mutations observed after failure of treatment with currently available NNRTIs. This study will provide an assessment of safety and a preliminary assessment of the efficacy of DPC 083 when administered at a dose of 100 mg once daily in combination with 2 NRTIs, in a population of HIV-1-infected patients who are failing treatment with an NNRTI-containing regimen.
Patients receive DPC 083 once daily in combination with 2 NRTIs. The 2 NRTIs are selected by the investigators, based on HIV-1 genotyping results. Analyses for patient safety and drug efficacy are done at Weeks 8, 24, and 48 using results from clinical laboratory tests and physical exams. Patients continue to receive DPC 083 and NRTIs until the last patient enrolled in the study completes 48 weeks of treatment. Patients return for post-therapy follow-up visits at 1 and 3 months following early termination or study completion. Some patients may participate in a substudy which evaluates changes in HIV-1 levels in cerebrospinal fluid (CSF).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007449
|United States, California|
|AIDS Healthcare Foundation|
|Los Angeles, California, United States, 90027|
|Orange Coast Med Group|
|Newport Beach, California, United States, 92663|
|United States, Florida|
|Bach and Godofsky|
|Bradenton, Florida, United States, 34205|
|Saint Josephs Comprehensive Research Institute|
|Tampa, Florida, United States, 33607|
|United States, Illinois|
|Northstar Med Clinic|
|Chicago, Illinois, United States, 60657|
|Principal Investigator:||James Stanford|
|Principal Investigator:||Daniel Berger|
|Principal Investigator:||Daniel Seekins|
|Principal Investigator:||Charles Walworth|