Status:
COMPLETED
A Pharmacokinetic (PK) Study of a Combination of Indinavir, Ritonavir, and Amprenavir
Lead Sponsor:
Emory University
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
When individuals who are infected with HIV are started on treatment with HIV medications, the effect of these drugs only lasts for a limited period of time, often because of development of drug resist...
Detailed Description
BACKGROUND: Because of their potent antiviral effects, protease inhibitor (PI)-containing antiretroviral regimens (ARV) have become one of the cornerstones of HIV treatment. Success with their use has...
Eligibility Criteria
Inclusion
- Age 18 years or more
- Diagnosis of HIV infection or AIDS as previously established by HIV ELISA test and confirmed by Western blot analysis
- Must have been taking and tolerating IDV/RTV 800/100 mg bid as part of an antiretroviral regimen.
Exclusion
- Hepatic abnormality: alanine-aminotransferase (ALT), aspartate- aminotransferase (AST) or total bilirubin (TBR) greater than 3x upper limit of normal
- Renal insufficiency: serum creatinine greater than 2 mg/dl
- Co-infection with hepatitis B and/or C viruses
- Pregnant or breastfeeding
- Use of concurrent medications known to affect IDV or APV concentrations significantly (e.g. rifampin, rifabutin, non-nucleoside reverse transcriptase inhibitor \[NNRTI\], other PIs, St John's Wort, herbal preparations)
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00148785
Start Date
July 1 2005
End Date
January 1 2007
Last Update
November 11 2013
Active Locations (1)
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1
Grady Infectious Diseases Program
Atlanta, Georgia, United States, 30308