Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00038532
First received: May 31, 2002
Last updated: March 29, 2008
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Amprenavir/ritonavir
Drug: Saquinavir/ritonavir
Drug: Efavirenz
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 24
Study Start Date: April 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038532

  Show 54 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Chair: Eugene Sun, M.D. Divisional Vice President, Infectious Diseases and Virology Development
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00038532     History of Changes
Obsolete Identifiers: NCT00021619
Other Study ID Numbers: M01-287
Study First Received: May 31, 2002
Last Updated: March 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
treatment experienced
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Amprenavir
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Ritonavir
Saquinavir
Anti-Bacterial Agents
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antibiotics, Antitubercular
Antitubercular Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014