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

NCT00004578 | Completed Phase 1

• 2 other identifiers: 285AM97-720
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

HIV Infections

Keywords

Stavudine; HIV Protease Inhibitors; Ritonavir; Lamivudine; Reverse Transcriptase Inhibitors

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with viral load below the limit of quantitation

  24 weeks

• Time to loss of virologic response

  48 weeks

Secondary Outcomes (1)

• Proportion of subjects with viral load below the limit of quantitation at each visit

  At each visit

Study Arms (2)

1

ACTIVE COMPARATOR

Group 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added.

Drug: Lopinavir/Ritonavir; Drug: Lamivudine; Drug: Stavudine

2

ACTIVE COMPARATOR

Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.

Drug: Lopinavir/Ritonavir; Drug: Lamivudine; Drug: Stavudine

Interventions

Lopinavir/Ritonavir DRUG

Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs

Also known as: ABT-387, Kaletra

1; 2

Lamivudine DRUG

150 mg, every 12 hours

1; 2

Stavudine DRUG

40 mg every 12 hours

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (10)

Pacific Oaks Research

Beverly Hills, California, 90211, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Northwestern University Medical School

Chicago, Illinois, 60611, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cornell Clinical Trials Unit - Chelsea Center

New York, New York, 10011, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related 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)

  BACKGROUND

• 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.

  PMID: 11192874 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Lopinavir; lopinavir-ritonavir drug combination; Lamivudine; Stavudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Officials

• George Hanna, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: November 1, 1997
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

US (10)