Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Mean change of VIH RNA between week 0 and week 26
- Disease progression
- CD4 cell count
- Safety
- Pharmacokinetics
- Genotypic resistance
Estimated Enrollment: | 100 |
Study Start Date: | November 2000 |
Estimated Study Completion Date: | February 2002 |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 |
Publications:
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 Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Amprenavir Lopinavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents |
ClinicalTrials.gov processed this record on October 16, 2012