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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00196625
Enrollment
100
Registered
2005-09-20
Start date
2000-11-01
Completion date
2002-02-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV infections, Salvage therapy, Amprenavir, Lopinavir, Ritonavir

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).

Interventions

DRUGAmprenavir (drug)
DRUGABT-378/r (drug)
DRUGRitonavir (drug)

Sponsors

ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Mean change of VIH RNA between week 0 and week 26

Secondary

MeasureTime frame
Disease progression
CD4 cell count
Safety
Pharmacokinetics
Genotypic resistance

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGilles Raguin, MD

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

STUDY_DIRECTORGenevieve Chene, MD, PhD

INSERM U593, Bordeaux, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026