HIV Infections Clinical Trial
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
| NCT number | NCT00004581 |
| Other study ID # | 285D |
| Secondary ID | M98-888 |
| Status | Completed |
| Phase | Phase 3 |
| First received | November 2, 1999 |
| Last updated | February 19, 2009 |
| Verified date | February 2009 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety Study, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Brisbane Hosp | Herston | |
| Austria | Pulmologisches Zentrum Der Stadt Wien | Wien | |
| Brazil | Hosp Evandro Chagas Fioernz | Manguinhos RJ | |
| Brazil | Castelo | Sao Paulo | |
| Brazil | Fundacao Zerbini Casa Da Aids | Sao Paulo | |
| Brazil | Hosp Do Servidor Publico Estadual De Sao Paulo | Sao Paulo | |
| Brazil | Hosp Heliopolis | Sao Paulo | |
| Canada | Clinique Medicale du Quartier Latin | Montreal | Quebec |
| Canada | Clinique Medicale L'Actuele | Montreal | Quebec |
| Canada | Montreal Chest Institute | Montreal | Quebec |
| Canada | Ottawa General Hospital | Ottawa | Ontario |
| Canada | Sunnybrook Health Science Ctr | Toronto | Ontario |
| Canada | Toronto Gen Hosp | Toronto | Ontario |
| Canada | Saint Paul's Hosp | Vancouver | British Columbia |
| Denmark | Righospitalet | Copenhagen | |
| Denmark | Hvidovre Univ Hosp | Hvidovre | |
| Denmark | Odense Univ Hosp | Odense C | |
| France | CHU De Bicetre | Paris | |
| France | Groupe Hospitalier Bichat-Claude Bernard | Paris Cedex 18 | |
| France | Hopital Gustave Dron | Tourcoing | |
| France | Hopital Paul Brousse | Villejuif | |
| 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 | |
| Poland | Ctr of AIDS Diagnosis and Treatment | Warszawa | |
| Puerto Rico | Ponce Univ Hosp | Ponce | |
| South Africa | Miller | Belford Gardens | |
| South Africa | Cyrildene | Johannesburg | |
| Spain | Hosp Germans Trias I Pujol | Barcelona | |
| Spain | Hosp Carlos III | Madrid | |
| Spain | Hosp De Mostoles | Madrid | |
| Spain | Hosp Doce De Octubre | Madrid | |
| Spain | Hosp La Paz | Madrid | |
| Spain | Hosp Virgen Del Rocio | Sevilla | |
| Switzerland | Universitatsspital Zurich | Zurich | |
| United Kingdom | Brighton Gen Hosp | Brighton | |
| United Kingdom | Chelsea and Westminster Hosp | London | |
| United Kingdom | Imperial College School of Medicine | London | |
| United Kingdom | Royal Free Hosp | London | |
| United States | Univ of Michigan Hospitals and Health Ctrs | Ann Arbor | Michigan |
| United States | Infectious Disease Physicians Inc | Annandale | Virginia |
| United States | AIDS Research Consortium of Atlanta | Atlanta | Georgia |
| United States | Emory Univ | Atlanta | Georgia |
| United States | Johns Hopkins Hosp | Baltimore | Maryland |
| United States | Pacific Oaks Med Group | Beverly Hills | California |
| United States | Univ of Alabama at Birmingham | Birmingham | Alabama |
| United States | Boston Med Ctr | Boston | Massachusetts |
| United States | Community Research Initiative of New England | Brookline | Massachusetts |
| United States | Univ of Virginia Health Sciences Ctr | Charlottesville | Virginia |
| United States | AIDS Research Alliance - Chicago | Chicago | Illinois |
| United States | Cook County Hosp | Chicago | Illinois |
| United States | Holmes Hosp / Univ of Cincinnati Med Ctr | Cincinnati | Ohio |
| United States | Oaklawn Physicians Group | Dallas | Texas |
| United States | Univ of Texas Southwestern Med Ctr | Dallas | Texas |
| United States | Duke Univ Med Ctr / Infectious Disease Clinic | Durham | North Carolina |
| United States | Orange County Ctr for Special Immunology | Fountain Valley | California |
| United States | Univ of Texas / Med Branch at Galveston | Galveston | Texas |
| United States | Joseph C Gathe | Houston | Texas |
| United States | Division of Inf Diseases/ Indiana Univ Hosp | Indianapolis | Indiana |
| United States | AIDS Healthcare Foundation | Los Angeles | California |
| United States | Tower ID Med Associates | Los Angeles | California |
| United States | UCLA CARE Ctr | Los Angeles | California |
| United States | Univ of Wisconsin | Madison | Wisconsin |
| United States | Univ of Miami School of Medicine | Miami | Florida |
| United States | Abbott Northwestern Hosp | Minneapolis | Minnesota |
| United States | Yale Univ / AIDS Clinical Trials Unit | New Haven | Connecticut |
| United States | Tulane Univ Med School | New Orleans | Louisiana |
| United States | Beth Israel Med Ctr | New York | New York |
| United States | Cornell Clinical Trials Unit - Chelsea Clinic | New York | New York |
| United States | Howard Grossman | New York | New York |
| United States | Saint Michael's Med Ctr / Dept of Infectious Diseases | Newark | New Jersey |
| United States | St Michaels Med Ctr | Newark | New Jersey |
| United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
| United States | Stephen Hauptman | Philadelphia | Pennsylvania |
| United States | Phoenix Body Positive | Phoenix | Arizona |
| United States | Oregon Health Sciences Univ | Portland | Oregon |
| United States | The Miriam Hosp | Providence | Rhode Island |
| United States | Univ of Utah Med School / Clinical Trials Ctr | Salt Lake City | Utah |
| United States | San Francisco Veterans Administration Med Ctr | San Francisco | California |
| United States | SUNY / Health Sciences Ctr at Stony Brook | Stony Brook | New York |
| United States | SUNY at Stony Brook / Div of Infectious Disease | Stony Brook | New York |
| United States | Infectious Disease Research Institute | Tampa | Florida |
| United States | Harbor - UCLA Med Ctr | Torrance | California |
| United States | Associates in Med and Mental Health | Tulsa | Oklahoma |
| United States | Univ of Kansas School of Medicine | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Poland, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom,
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