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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis


Information provided by (Responsible Party)
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier
NCT00196625

First received: September 12, 2005
Last updated: September 12, 2005
Last Verified: September 2005
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: None (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

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

Enrollment: 100
Study Start Date: November 2000
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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
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  

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV infections
Salvage therapy
Amprenavir
Lopinavir
Ritonavir

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
Amprenavir

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.