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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00004580 |
The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Nevirapine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks.
Patients must have:
- HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening.
Prior Medication:
Allowed:
Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors.
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
United States, California | |
San Francisco Gen Hosp / UCSF AIDS Program | |
San Francisco, California, United States, 94110 | |
Pacific Oaks Research | |
Beverly Hills, California, United States, 90211 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise | |
Chicago, Illinois, United States, 60612 | |
United States, North Carolina | |
Univ North Carolina at Chapel Hill / Dept of Medicine | |
Chapel Hill, North Carolina, United States, 27599 | |
Duke Univ Med Ctr / Infectious Disease Clinic | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405 | |
Cincinnati, Ohio, United States, 452670405 | |
United States, Pennsylvania | |
Univ of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 152132582 | |
United States, Virginia | |
Infectious Disease Physicians Inc | |
Annandale, Virginia, United States, 22203 |
Study ID Numbers: | 285B, M97-765 |
Study First Received: | November 2, 1999 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00004580 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Nevirapine HIV Protease Inhibitors Ritonavir Reverse Transcriptase Inhibitors |
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Protease Inhibitors |
Virus Diseases Nevirapine Anti-Retroviral Agents Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents |
Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Nevirapine HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |