Genetic Predictors of Variability in the Drug-Drug Interaction Between Darunavir/Ritonavir and Pravastatin
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, HIV / AIDS |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/11/2012 |
| Start Date: | February 2008 |
| End Date: | July 2009 |
| Contact: | Christina L Aquilante, PharmD |
| Email: | christina.aquilante@uchsc.edu |
| Phone: | 303-315-3119 |
Genetic Predictors of Pharmacokinetic Variability in the Drug-Drug Interaction Between Darunavir/Ritonavir and Pravastatin: the Role of SLCO1B1 Polymorphisms.
Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to
treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the
Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are
given with pravastatin, they can increase the blood levels of pravastatin. The degree of
this interaction varies from person to person. The way that darunavir and ritonavir
interact with pravastatin may be affected by a person's genetic make-up. Genetic factors
(or DNA) are those that people are born with and that make each person unique. Genetic
differences are the reason why one person's body traits such as height and hair color are
different from another person's body traits. Genetic differences can also affect the way a
medication works in the body or the way two medications interact in the body. The purpose
of this clinical study is to determine if a person's genetic make-up affects the way
darunavir and ritonavir interact with pravastatin in the body.
Inclusion Criteria:
- Healthy, HIV-negative volunteers
Exclusion Criteria:
- Currently active or chronic cardiovascular, hepatic, renal, pancreatic,
gastrointestinal, neurologic, hematologic, psychiatric, metabolic, respiratory,
inflammatory, or infectious disease
- Chronic pancreatitis
- History of rhabdomyolysis
- History of statin-associated myopathy
- Active malignancy
- History of significant skin disease, food allergy, drug allergy, dermatitis, eczema,
psoriasis
- Pregnancy/breastfeeding
- HIV positive and/or AIDS
- serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range
[ULN]);
- hemoglobin grade 1 or greater (≤ 10.9 g/dL);
- platelet count grade 1 or greater (≤ 124.999 x 109/L);
- absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L);
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater
(≥ 1.25 x ULN);
- total bilirubin grade 1 or greater (≥ 1.1 x ULN)
- serum lipase grade 1 or greater (≥ 1.1 x ULN)
- serum amylase grade 1 or greater (≥ 1.1 x ULN)
- any other laboratory abnormality of grade 2 or above
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