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 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Stavudine Lamivudine Ritonavir Nelfinavir Nelfinavir Mesylate Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.


ClinicalTrials.gov Identifier:	NCT00004583 History of Changes
Other Study ID Numbers:	285C, M98-863
Study First Received:	November 2, 1999
Last Updated:	February 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:


Drug Therapy, Combination Administration, Oral Stavudine HIV Protease Inhibitors Lamivudine	Reverse Transcriptase Inhibitors Anti-HIV Agents Nelfinavir ABT 378

Additional relevant MeSH terms:


Lamivudine Nelfinavir Stavudine Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antimetabolites Antiviral Agents	Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015