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

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.

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00038519
Enrollment
16
Registered
2002-06-03
Start date
2001-04-30
Completion date
Unknown
Last updated
2006-07-28

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

Conditions

HIV Infections

Keywords

treatment experienced, HIV

Brief summary

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.

Interventions

Sponsors

Abbott
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Argentina, Brazil, Canada, France, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026