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

NCT00196625 | Completed Phase 2

• 1 other identifier: ANRS 104 PUZZLE1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV Infections

Keywords

HIV infections; Salvage therapy; Amprenavir; Lopinavir; Ritonavir

Outcome Measures

Primary Outcomes (1)

• Mean change of VIH RNA between week 0 and week 26

Secondary Outcomes (5)

• Disease progression

• CD4 cell count

• Safety

• Pharmacokinetics

• Genotypic resistance

Interventions

Amprenavir (drug) DRUG

ABT-378/r (drug) DRUG

Ritonavir (drug) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Related Publications (2)

• Raguin G, Chene G, Morand-Joubert L, Taburet AM, Droz C, Le Tiec C, Clavel F, Girard PM; Puzzle 1 Study Group. Salvage therapy with amprenavir, lopinavir and ritonavir 200 mg/d or 400 mg/d in HIV-infected patients in virological failure. Antivir Ther. 2004 Aug;9(4):615-25.

  PMID: 15456093 RESULT

• Taburet AM, Raguin G, Le Tiec C, Droz C, Barrail A, Vincent I, Morand-Joubert L, Chene G, Clavel F, Girard PM. Interactions between amprenavir and the lopinavir-ritonavir combination in heavily pretreated patients infected with human immunodeficiency virus. Clin Pharmacol Ther. 2004 Apr;75(4):310-23. doi: 10.1016/j.clpt.2003.12.013.

  PMID: 15060509 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

amprenavir; Pharmaceutical Preparations; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gilles Raguin, MD

  Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine, Paris, France

  PRINCIPAL INVESTIGATOR

• Genevieve Chene, MD, PhD

  INSERM U593, Bordeaux, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2000
• Study Completion: February 1, 2002
• Last Updated: September 20, 2005

Record last verified: 2005-09