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OpenTrials
Completed

NCT Number: NCT00196625

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine

Paris, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amprenavir (drug)

Drug

ABT-378/r (drug)

Drug

Ritonavir (drug)

Drug

Primary outcomes

  1. Mean change of VIH RNA between week 0 and week 26

Secondary outcomes

  1. Disease progression

  2. CD4 cell count

  3. Safety

  4. Pharmacokinetics

  5. Genotypic resistance

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study 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

Important dates

Study start
2000
Study completion
2002
First posted
Sep 20, 2005
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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