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

NCT ID: NCT00196625

Last Updated: 2005-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2002-02-28

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.

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).

Conditions

HIV Infections

Keywords

HIV infections; Salvage therapy; Amprenavir; Lopinavir; Ritonavir

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Amprenavir (drug)

Intervention Type: DRUG

ABT-378/r (drug)

Intervention Type: DRUG

Ritonavir (drug)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Gilles Raguin, MD

Role: PRINCIPAL_INVESTIGATOR

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

Genevieve Chene, MD, PhD

Role: STUDY_DIRECTOR

INSERM U593, Bordeaux, France

References

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.

Reference Type: RESULT

PMID: 15456093 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15060509 (View on PubMed)

Other Identifiers

ANRS 104 PUZZLE1

Identifier Type: -

Identifier Source: org_study_id