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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00004580 |
Purpose
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 |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Nevirapine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients |
Eligibility| 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:
Contacts and Locations| United States, California | |
| Pacific Oaks Research | |
| Beverly Hills, California, United States, 90211 | |
| San Francisco Gen Hosp / UCSF AIDS Program | |
| San Francisco, California, United States, 94110 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00004580 History of Changes |
| Other Study ID Numbers: | 285B, M97-765 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 19, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Nevirapine HIV Protease Inhibitors Ritonavir Reverse Transcriptase Inhibitors |
|
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 Protease Inhibitors Ritonavir |
Lopinavir Nevirapine Reverse Transcriptase Inhibitors HIV Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |