Expired Study
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Atlanta, Georgia 30308


Purpose:

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.


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.


Study is Available At:


Original ID:

M00-261


NCT ID:

NCT00038519


Secondary ID:


Study Acronym:


Brief Title:

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


Official 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.


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:


Overall Contact Information

Official Name:Eugene Sun, M.D.
Study Chair
Divisional Vice President, Infectious Diseases and Virology Development

Study Dates

Start Date:April 2001
Verification Date:July 2006
Last Changed Date:July 27, 2006
First Received Date:May 31, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Amprenavir/ritonavir
Intervention Type:Drug
Name:Saquinavir/ritonavir

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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