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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Amprenavir Lopinavir

U.S. FDA Resources

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


Estimated Enrollment:	100
Study Start Date:	November 2000
Estimated 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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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

Publications:

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. 2004 Aug;9(4):615-25.

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 virus. Clin Pharmacol Ther. 2004 Apr;75(4):310-23.


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
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Amprenavir HIV Protease Inhibitors	Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 27, 2016