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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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DPC 083
Sponsored by
Dupont Applied Biosciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible for this study if they: Have HIV infection. Are at least 18 years old. Weigh at least 50 kg. Have documented evidence of virologic failure. Have screening HIV genotype done while receiving NNRTI treatment, or within 2 weeks after stopping the treatment. Have a viral load (amount of HIV in the blood) of at least 1,000 copies/ml within 45 days prior to Day 1 of study. Are willing to use an effective barrier method of birth control during the study. Birth control agents taken by mouth or placed under the skin should not be used as the only method of birth control. If the patient stops taking the study drug, he or she should continue to use birth control for the following 3 months. Exclusion Criteria Patients will not be eligible for this study if they: Had virologic failure of any treatment containing an HIV protease inhibitor drug. Had virologic failure of more than 1 treatment containing an NNRTI drug. Have participated in any study using DPC 083. Were treated with any experimental NNRTI. Have cancer that requires systemic therapy. Have a history of blood clotting problems. Have attempted suicide or are in danger of hurting themselves. Used illegal injection drugs within 6 months of study entry. Do not expect to complete 12 months on the study. Have not met requirements for HIV genotyping results. Have any disease other than HIV infection or other medical problems that the researchers think may interfere with the study. Have difficulty swallowing capsules/tablets. Have had treatment with immunomodulatory agents such as interferons, interleukins, or thalidomide within 30 days prior to study entry. Are using or have used systemic drugs, including glucocorticoids, that suppress the immune system, for over 2 weeks. (Low levels of prednisone are allowed.) Have used carbamazepine, phenytoin, or Hypericum perforatum (St. John's wort) within 30 days of beginning study treatment. Have had any vaccination within 3 weeks before study screening. Have received any experimental therapy within 30 days of beginning study treatment. Are pregnant or breast-feeding. Abuse alcohol or drugs.

Sites / Locations

  • AIDS Healthcare Foundation
  • Orange Coast Med Group
  • Bach and Godofsky
  • Saint Josephs Comprehensive Research Institute
  • Northstar Med Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 19, 2000
Last Updated
June 23, 2005
Sponsor
Dupont Applied Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT00007449
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2002
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dupont Applied Biosciences

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DPC 083

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Have HIV infection. Are at least 18 years old. Weigh at least 50 kg. Have documented evidence of virologic failure. Have screening HIV genotype done while receiving NNRTI treatment, or within 2 weeks after stopping the treatment. Have a viral load (amount of HIV in the blood) of at least 1,000 copies/ml within 45 days prior to Day 1 of study. Are willing to use an effective barrier method of birth control during the study. Birth control agents taken by mouth or placed under the skin should not be used as the only method of birth control. If the patient stops taking the study drug, he or she should continue to use birth control for the following 3 months. Exclusion Criteria Patients will not be eligible for this study if they: Had virologic failure of any treatment containing an HIV protease inhibitor drug. Had virologic failure of more than 1 treatment containing an NNRTI drug. Have participated in any study using DPC 083. Were treated with any experimental NNRTI. Have cancer that requires systemic therapy. Have a history of blood clotting problems. Have attempted suicide or are in danger of hurting themselves. Used illegal injection drugs within 6 months of study entry. Do not expect to complete 12 months on the study. Have not met requirements for HIV genotyping results. Have any disease other than HIV infection or other medical problems that the researchers think may interfere with the study. Have difficulty swallowing capsules/tablets. Have had treatment with immunomodulatory agents such as interferons, interleukins, or thalidomide within 30 days prior to study entry. Are using or have used systemic drugs, including glucocorticoids, that suppress the immune system, for over 2 weeks. (Low levels of prednisone are allowed.) Have used carbamazepine, phenytoin, or Hypericum perforatum (St. John's wort) within 30 days of beginning study treatment. Have had any vaccination within 3 weeks before study screening. Have received any experimental therapy within 30 days of beginning study treatment. Are pregnant or breast-feeding. Abuse alcohol or drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Stanford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Berger
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Seekins
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Walworth
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Orange Coast Med Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Bach and Godofsky
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Saint Josephs Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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