Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
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ClinicalTrials.gov Identifier: NCT00038519 |
Recruitment Status
:
Completed
First Posted
: June 3, 2002
Last Update Posted
: July 28, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Amprenavir/ritonavir Drug: Saquinavir/ritonavir | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | April 2001 |

- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038519

Study Chair: | Eugene Sun, M.D. | Divisional Vice President, Infectious Diseases and Virology Development |
ClinicalTrials.gov Identifier: | NCT00038519 History of Changes |
Other Study ID Numbers: |
M00-261 |
First Posted: | June 3, 2002 Key Record Dates |
Last Update Posted: | July 28, 2006 |
Last Verified: | July 2006 |
Keywords provided by Abbott:
treatment experienced HIV |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir HIV Protease Inhibitors Saquinavir Amprenavir |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents |