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ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004578
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
November 2, 1999
August 31, 2001
March 17, 2014
November 1997
April 2005   (Final data collection date for primary outcome measure)
  • Proportion of subjects with viral load below the limit of quantitation [ Time Frame: 24 weeks ]
  • Time to loss of virologic response [ Time Frame: 48 weeks ]
Not Provided
Complete list of historical versions of study NCT00004578 on ClinicalTrials.gov Archive Site
Proportion of subjects with viral load below the limit of quantitation at each visit [ Time Frame: At each visit ]
Not Provided
Not Provided
Not Provided
 
ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: Lopinavir/Ritonavir
    Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
    Other Names:
    • ABT-387
    • Kaletra
  • Drug: Lamivudine
    150 mg, every 12 hours
  • Drug: Stavudine
    40 mg every 12 hours
  • Active Comparator: 1
    Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
    Interventions:
    • Drug: Lopinavir/Ritonavir
    • Drug: Lamivudine
    • Drug: Stavudine
  • Active Comparator: 2
    Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
    Interventions:
    • Drug: Lopinavir/Ritonavir
    • Drug: Lamivudine
    • Drug: Stavudine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2005
April 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004578
285A
M97-720
No
Not Provided
Not Provided
George Hanna, MD, Anti-viral Global Project Head, Abbott
Abbott
Not Provided
Study Director: George Hanna, MD Abbott
Abbott
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP