Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.
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| ClinicalTrials.gov Identifier: NCT00196625 |
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Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: September 20, 2005
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Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Amprenavir (drug) Drug: ABT-378/r (drug) Drug: Ritonavir (drug) | Phase 2 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | November 2000 |
| Study Completion Date : | February 2002 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00196625 History of Changes |
| Other Study ID Numbers: |
ANRS 104 PUZZLE1 |
| First Posted: | September 20, 2005 Key Record Dates |
| Last Update Posted: | September 20, 2005 |
| Last Verified: | September 2005 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
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HIV infections Salvage therapy Amprenavir Lopinavir Ritonavir |
Additional relevant MeSH terms:
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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 |