A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy - Full Text View

Purpose

The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

Condition	Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine	Phase III

MedlinePlus related topics:

AIDS AIDS Medicines

Drug Information available for:

Lamivudine Stavudine Nelfinavir Nelfinavir Mesylate Ritonavir Lopinavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Efficacy Study

Official Title:	A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine Vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	660
Study Start Date:	March 1999

Detailed Description:

Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.

Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

You may be eligible for this trial if you:

Are HIV positive.
Have a viral load (level of HIV in your blood) of more than 400 copies/ml.
Are age 12 or older.
Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this trial if you:

Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC.
Are seriously ill or have an AIDS-related infection.
Are pregnant or breast-feeding.
Are taking certain medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004583

Show 83 Study Locations

Sponsors and Collaborators

Abbott

More Information

Publications:

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.

Study ID Numbers:	285C, M98-863
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004583
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination

Administration, Oral

Stavudine

HIV Protease Inhibitors

Lamivudine

Reverse Transcriptase Inhibitors

Anti-HIV Agents

Nelfinavir

ABT 378

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Stavudine

Acquired Immunodeficiency Syndrome

Lamivudine

Immunologic Deficiency Syndromes

Virus Diseases

HIV Seropositivity

Lopinavir

HIV Infections

Ritonavir

Sexually Transmitted Diseases

Nelfinavir

Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Abbott
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00004583