Back to resultsABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lopinavir/Ritonavir
Lamivudine
Stavudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Reverse Transcriptase Inhibitors
Eligibility Criteria
Inclusion Criteria HIV-1 positive antiretroviral-adult males non-pregnant non-lactating females at least 18-years old with plasma HIV-1 RNA > 5000 copies/mL, who were not acutely ill Exclusion Criteria History of: prior antiretroviral therapy significant drug hypersensitivity psychiatric illness that precludes compliance an active substance abuser positive test results for drug abuse abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results pregnancy or lactating female received another investigational drug within 28 days of study initiation unlikely to comply or unsuitable candidate in the opinion of the investigator
Sites / Locations
- Pacific Oaks Research
- University of Colorado Health Sciences Center
- AIDS Research Consortium of Atlanta
- Northwestern University Medical School
- Rush-Presbyterian-St. Luke's Medical Center
- Beth Israel Deaconess Medical Center
- Cornell Clinical Trials Unit - Chelsea Center
- University of North Carolina at Chapel Hill
- Duke University Medical Center
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
Outcomes
Primary Outcome Measures
Proportion of subjects with viral load below the limit of quantitation
Time to loss of virologic response
Secondary Outcome Measures
Proportion of subjects with viral load below the limit of quantitation at each visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00004578
Brief Title
ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
Official Title
Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Reverse Transcriptase Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Other Intervention Name(s)
ABT-387, Kaletra
Intervention Description
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
150 mg, every 12 hours
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Description
40 mg every 12 hours
Primary Outcome Measure Information:
Title
Proportion of subjects with viral load below the limit of quantitation
Time Frame
24 weeks
Title
Time to loss of virologic response
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with viral load below the limit of quantitation at each visit
Time Frame
At each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
HIV-1 positive
antiretroviral-adult males
non-pregnant
non-lactating females at least 18-years old with plasma HIV-1 RNA > 5000 copies/mL, who were not acutely ill
Exclusion Criteria
History of:
prior antiretroviral therapy
significant drug hypersensitivity
psychiatric illness that precludes compliance
an active substance abuser
positive test results for drug abuse
abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results
pregnancy or lactating female
received another investigational drug within 28 days of study initiation
unlikely to comply or unsuitable candidate in the opinion of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Hanna, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern University Medical School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cornell Clinical Trials Unit - Chelsea Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Murphy R, King M, Brun S, Orth K, Hicks C, Eron J, Thommes J, Gulick R, Thompson M, White C, Benson C, Hammer S, Kessler H, Bertz R, Hsu A, Kempf D, Sun E, Japour A. ABT-378/ritonavir therapy in antiretroviral-naive HIV-I infected patients for 24 weeks. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:69 (abstract no 15)
Results Reference
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PubMed Identifier
11192874
Citation
Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.
Results Reference
background
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ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
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