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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00004578
First received: November 2, 1999
Last updated: April 2, 2008
Last verified: April 2008

November 2, 1999
April 2, 2008
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 ] [ Designated as safety issue: No ]
  • Time to loss of virologic response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    • Lopinavir/Ritonavir
  • Drug: Lamivudine
    150 mg, every 12 hours
    Other Name: Lamivudine
  • Drug: Stavudine
    40 mg every 12 hours
    Other Name: Stavudine
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004578
285A, M97-720
No
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