HIV Infections Clinical Trial
Official title:
An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
| NCT number | NCT00038532 |
| Other study ID # | M01-287 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | May 31, 2002 |
| Last updated | March 29, 2008 |
| Start date | April 2001 |
| Verified date | July 2006 |
| 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 study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion: - Remain on present anti-HIV drugs during screening until a new regimen is started. - Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it. - Have an HIV which shows reduced susceptibility to lopinavir. - Are at least 18 years old. - Are not presently ill. - Have not been treated for an opportunistic infection within 30 days of screening. - Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs. - Agree to use an accepted barrier method of birth control. Exclusion: - Female subject is pregnant or lactating. - Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks. - Are taking chemotherapy. - Have a medical problem with their pancreas. - Have been screened for this study within the past 12 weeks. - Appear to be unsuitable in the opinion of the doctor. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundacion Huesped | Buenos Aires | |
| Argentina | Hospital Muniz - FUNDAI | Buenos Aires | |
| Brazil | Hospital Heliopolis | Sao Paulo | |
| Canada | Montreal Chest Institute/Royal Victoria Hospital | Montreal | Quebec |
| Canada | Ottawa Hospital General Campus | Ottawa | Ontario |
| Canada | Toronto General Hospital Division of The University Health Network | Toronto | Ontario |
| France | Hopital Michalon - C.H.U. de Grenoble | Grenoble | |
| France | Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon | Paris | |
| France | Hopital Tenon | Paris | |
| France | Hospital Yves Le Foll | Saint Brieuc | |
| France | La Seyne sur Mer, Hopital Chalucet | Toulon | |
| France | C.H.U. Brabois - Tour Drouet, Rue du Morvan | Vandoeuvre | |
| Germany | CORE Center | Berlin | |
| Germany | Universitatsklinikum | Dusseldorf | |
| Germany | Klinikum J.W. Goethe Universitat | Frankfurt | |
| Germany | Institut fur Immunologie Pathologie und Molekularbiologie | Hamburg | |
| Germany | Albrecht Ulmer, M.D. | Stuttgart | |
| Italy | S. Raffaele Hospital | Milan | |
| Poland | Wojewodzki Szpital Zakazny | Warszawa | |
| Puerto Rico | Centro Familiar, Inc | Ponce | |
| Puerto Rico | New Puerto Rico CONCRA | Rio Piedras | |
| Spain | Hospital Germans Trias I Pujol | Badalona | |
| Spain | Hospital Clinic I Provincial | Barcelona | |
| Spain | Hospital De La Sta Creu I San Pau | Barcelona | |
| Spain | Hospital La Paz | Madrid | |
| Spain | Hospital Carlos III | Madrid, | |
| Spain | Hospital Universitario Vergen del Rocio | Sevilla | |
| United Kingdom | Royal Free Hospital | London, | |
| United States | IDC Research Initiative | Altamonte Springs | Florida |
| United States | AIDS Research Consortium of Atlanta, Inc. | Atlanta | Georgia |
| United States | David Wright, M.D. | Austin | Texas |
| United States | CORE Center | Chicago | Illinois |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | 20th Avenue Medical Center Kaiser Permanente | Denver | Colorado |
| United States | University of Colorado Health Sciences Center | Denver | Colorado |
| United States | Associates in Research | Fort Myers | Florida |
| United States | Paul J. Cimoch, M.D. | Fountain Valley | California |
| United States | Gary J. Richmond, M.D. | Ft. Lauderdale | Florida |
| United States | University of Texas Medical Branch | Galveston | Texas |
| United States | Hampton Roads Medical Specialists | Hampton | Virginia |
| United States | Diversified Medical Practices, P.A. | Houston | Texas |
| United States | AIDS Health Care Foundation - Research Center | Los Angeles | California |
| United States | Tower Infectious Diseases Medical Associates | Los Angeles | California |
| United States | University of Miami School of Medicine | Miami | Florida |
| United States | Howard A. Grossman, M.D. | New York | New York |
| United States | John B. Montana, M.D. | New York, | New York |
| United States | Saint Michael's Medical Center | Newark | New Jersey |
| United States | Phoenix Body Positive, Inc. | Phoenix, | Arizona |
| United States | The Research & Education Group | Portland | Oregon |
| United States | Bornemann Internal Medicine | Reading | Pennsylvania |
| United States | David Parks, M.D. | St. Louis | Missouri |
| United States | State University of New York at Stony Brook | Stony Brook, | New York |
| United States | Infectious Disease Research Institute, Inc. | Tampa | Florida |
| United States | Donna E. Sweet, M.D. | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States, Argentina, Brazil, Canada, France, Germany, Italy, Poland, Puerto Rico, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48 |
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