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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

September 12, 2005
September 12, 2005
November 2000
Not Provided
Mean change of VIH RNA between week 0 and week 26
Same as current
No Changes Posted
  • Disease progression
  • CD4 cell count
  • Safety
  • Pharmacokinetics
  • Genotypic resistance
Same as current
Not Provided
Not Provided
 
Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.
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

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Amprenavir (drug)
  • Drug: ABT-378/r (drug)
  • Drug: Ritonavir (drug)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2002
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00196625
ANRS 104 PUZZLE1
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
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
French National Agency for Research on AIDS and Viral Hepatitis
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP