Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor

The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.

Completed

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fundacion Huesped, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.
Subject demonstrates reduced susceptibility to lopinavir.
Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.
The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.
Subject is at least 18 years of age.
Subject has not been treated for an active opportunistic infection within 30 days of screening.

Exclusion:

Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.
Female subject pregnant or lactating.
Use of an Investigational drug within 30 days prior to the initiation of drug dosing.
Subject is receiving systemic chemotherapy.
Subject has a history of acute or chronic pancreatitis.

Treatment and study plan

Amprenavir/ritonavir

Drug

Saquinavir/ritonavir

Drug

Primary outcomes

Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.

Important dates

Study start: 2001
First posted: Jun 3, 2002
Registry last updated: Jul 28, 2006

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.

Published trials that share one or more normalized conditions with this study.

Completed