Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00196625
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.


Condition Intervention Phase
HIV Infections
Drug: Amprenavir (drug)
Drug: ABT-378/r (drug)
Drug: Ritonavir (drug)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study on Safety and Efficacy of Salvage Therapy With Amprenavir, Lopinavir and Ritonavir 200 Mg/d or 400 Mg/d in HIV-Infected Patients in Virological Failure.ANRS 104 PUZZLE 1

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Mean change of VIH RNA between week 0 and week 26

Secondary Outcome Measures:
  • Disease progression
  • CD4 cell count
  • Safety
  • Pharmacokinetics
  • Genotypic resistance

Estimated Enrollment: 100
Study Start Date: November 2000
Estimated Study Completion Date: February 2002
Detailed Description:

HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors (NRTI), over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed. 100 patients with CD4 cell count below 300/mm3 and plasma HIV RNA over 30,000 copies/ml are to be included in four groups: amprenavir, lopinavir, NRTI, with ritonavir 200 mg.d or not (patients previously treated by additional ritonavir 200 or 400 mg/d).

  Eligibility

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

Inclusion Criteria:

  • Documented HIV infection
  • CD4 cell count below 300/mm3
  • Plasma HIV RNA over 30,000 copies/ml
  • Previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir)
  • Written informed consent

Exclusion Criteria:

  • Biological abnormalities
  • Pregnancy
  • Alcool abuse
  • History of pancreatitis, hepatic failure
  • Acute HIV related infection
  • Chemotherapy
  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: NCT00196625

Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Gilles Raguin, MD Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine, Paris, France
Study Director: Genevieve Chene, MD, PhD INSERM U593, Bordeaux, France
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00196625     History of Changes
Other Study ID Numbers: ANRS 104 PUZZLE1
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infections
Salvage therapy
Amprenavir
Lopinavir
Ritonavir

Additional relevant MeSH terms:
Infection
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
Lopinavir
Ritonavir
Amprenavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on October 19, 2014