A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
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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 |
| Estimated Enrollment: | 660 |
| Study Start Date: | March 1999 |
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 |
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
Show 83 Study Locations More Information
Publications:
| 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:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases HIV Protease Inhibitors Ritonavir Nelfinavir Lopinavir |
Stavudine Lamivudine Reverse Transcriptase Inhibitors Anti-HIV Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Antimetabolites Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013