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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196625
• Other study ID #: ANRS 104 PUZZLE1
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: November 2000
• Est. completion date: February 2002

Study information

• Verified date: September 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Amprenavir (drug)

• ABT-378/r (drug)

• Ritonavir (drug)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

References & Publications (2)

Raguin G, Chêne 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. 200 — View Citation

Taburet AM, Raguin G, Le Tiec C, Droz C, Barrail A, Vincent I, Morand-Joubert L, Chêne G, Clavel F, Girard PM. Interactions between amprenavir and the lopinavir-ritonavir combination in heavily pretreated patients infected with human immunodeficiency viru — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of VIH RNA between week 0 and week 26
Secondary	Disease progression
Secondary	CD4 cell count
Secondary	Safety
Secondary	Pharmacokinetics
Secondary	Genotypic resistance