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

HIV Infections Clinical Trial

Official title:

Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004578
• Other study ID #: 285A
• Secondary ID: M97-720
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 2, 1999
• Last updated: April 2, 2008
• Start date: November 1997
• Est. completion date: April 2005

Study information

• Verified date: April 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

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
• Lamivudine
150 mg, every 12 hours
• Stavudine
40 mg every 12 hours

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Pacific Oaks Research	Beverly Hills	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University Medical School	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Cornell Clinical Trials Unit - Chelsea Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

References & Publications (2)

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)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with viral load below the limit of quantitation		24 weeks	No
Primary	Time to loss of virologic response		48 weeks	No
Secondary	Proportion of subjects with viral load below the limit of quantitation at each visit		At each visit	No