A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00004581
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
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Purpose
The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Nevirapine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects |
Resource links provided by NLM:
Further study details as provided by Abbott:
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are at least 12 years old.
- Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
- Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
- Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
- Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have an active illness.
- Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
- Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
- Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
- Have received treatment with a PI other than their current PI.
- Are receiving chemotherapy for cancer.
- Are pregnant or breast-feeding.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004581
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| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Pacific Oaks Med Group | |
| Beverly Hills, California, United States, 90211 | |
| Orange County Ctr for Special Immunology | |
| Fountain Valley, California, United States, 92708 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 900276069 | |
| Tower ID Med Associates | |
| Los Angeles, California, United States, 90048 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Connecticut | |
| Yale Univ / AIDS Clinical Trials Unit | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Infectious Disease Research Institute | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Emory Univ | |
| Atlanta, Georgia, United States, 30308 | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Division of Inf Diseases/ Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| Community Research Initiative of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, Michigan | |
| Univ of Michigan Hospitals and Health Ctrs | |
| Ann Arbor, Michigan, United States, 481090378 | |
| United States, Minnesota | |
| Abbott Northwestern Hosp | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New Jersey | |
| Saint Michael's Med Ctr / Dept of Infectious Diseases | |
| Newark, New Jersey, United States, 07102 | |
| St Michaels Med Ctr | |
| Newark, New Jersey, United States, 07102 | |
| United States, New York | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Howard Grossman | |
| New York, New York, United States, 10011 | |
| Cornell Clinical Trials Unit - Chelsea Clinic | |
| New York, New York, United States, 10011 | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| SUNY at Stony Brook / Div of Infectious Disease | |
| Stony Brook, New York, United States, 117948153 | |
| United States, North Carolina | |
| Duke Univ Med Ctr / Infectious Disease Clinic | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Holmes Hosp / Univ of Cincinnati Med Ctr | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Oklahoma | |
| Associates in Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Oregon | |
| Oregon Health Sciences Univ | |
| Portland, Oregon, United States, 972109951 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Stephen Hauptman | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| The Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75235 | |
| Oaklawn Physicians Group | |
| Dallas, Texas, United States, 75219 | |
| Univ of Texas / Med Branch at Galveston | |
| Galveston, Texas, United States, 775550835 | |
| Joseph C Gathe | |
| Houston, Texas, United States, 77004 | |
| United States, Utah | |
| Univ of Utah Med School / Clinical Trials Ctr | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| Univ of Virginia Health Sciences Ctr | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Wisconsin | |
| Univ of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Australia | |
| Royal Brisbane Hosp | |
| Herston, Australia | |
| Austria | |
| Pulmologisches Zentrum Der Stadt Wien | |
| Wien, Austria | |
| Brazil | |
| Hosp Evandro Chagas Fioernz | |
| Manguinhos RJ, Brazil | |
| Hosp Do Servidor Publico Estadual De Sao Paulo | |
| Sao Paulo, Brazil | |
| Hosp Heliopolis | |
| Sao Paulo, Brazil | |
| Fundacao Zerbini Casa Da Aids | |
| Sao Paulo, Brazil | |
| Castelo | |
| Sao Paulo, Brazil | |
| Canada, British Columbia | |
| Saint Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Ottawa General Hospital | |
| Ottawa, Ontario, Canada | |
| Sunnybrook Health Science Ctr | |
| Toronto, Ontario, Canada | |
| Toronto Gen Hosp | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Montreal Chest Institute | |
| Montreal, Quebec, Canada | |
| Clinique Medicale L'Actuele | |
| Montreal, Quebec, Canada | |
| Clinique Medicale du Quartier Latin | |
| Montreal, Quebec, Canada | |
| Denmark | |
| Righospitalet | |
| Copenhagen, Denmark | |
| Hvidovre Univ Hosp | |
| Hvidovre, Denmark | |
| Odense Univ Hosp | |
| Odense C, Denmark | |
| France | |
| CHU De Bicetre | |
| Paris, France | |
| Groupe Hospitalier Bichat-Claude Bernard | |
| Paris Cedex 18, France | |
| Hopital Gustave Dron | |
| Tourcoing, France | |
| Hopital Paul Brousse | |
| Villejuif, France | |
| Germany | |
| EPIMED | |
| Berlin, Germany | |
| Heinrich Heine Universitat | |
| Dusseldorf, Germany | |
| Klinikum Der Johann Wolfgang Goethe Universitat | |
| Frankfurt, Germany | |
| Allgemeines Krankenhaus St Georg | |
| Hamburg, Germany | |
| Univ Zu Koeln | |
| Koeln, Germany | |
| Aids Study Group Mannheim | |
| Mannheim, Germany | |
| Poland | |
| Ctr of AIDS Diagnosis and Treatment | |
| Warszawa, Poland | |
| Puerto Rico | |
| Ponce Univ Hosp | |
| Ponce, Puerto Rico, 00731 | |
| South Africa | |
| Miller | |
| Belford Gardens, South Africa | |
| Cyrildene | |
| Johannesburg, South Africa | |
| Spain | |
| Hosp Germans Trias I Pujol | |
| Barcelona, Spain | |
| Hosp De Mostoles | |
| Madrid, Spain | |
| Hosp La Paz | |
| Madrid, Spain | |
| Hosp Carlos III | |
| Madrid, Spain | |
| Hosp Doce De Octubre | |
| Madrid, Spain | |
| Hosp Virgen Del Rocio | |
| Sevilla, Spain | |
| Switzerland | |
| Universitatsspital Zurich | |
| Zurich, Switzerland | |
| United Kingdom | |
| Brighton Gen Hosp | |
| Brighton, United Kingdom | |
| Imperial College School of Medicine | |
| London, United Kingdom | |
| Chelsea and Westminster Hosp | |
| London, United Kingdom | |
| Royal Free Hosp | |
| London, United Kingdom | |
Sponsors and Collaborators
Abbott
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004581 History of Changes |
| Other Study ID Numbers: | 285D, M98-888 |
| 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 Nevirapine HIV Protease Inhibitors Ritonavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents 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 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 |
ClinicalTrials.gov processed this record on May 23, 2013