| February 28, 2008 |
| March 6, 2008 |
| February 2008 |
| March 2009 (final data collection date for primary outcome measure) |
| Change in pravastatin AUC when pravastatin is administered with and without darunavir/ritonavir. [ Time Frame: multiple dose pravastatin (4 days) ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00630734 on ClinicalTrials.gov Archive Site |
| Change in pravastatin Cmax, tmax, t1/2, and oral clearance when pravastatin is administered with and without darunavir/ritonavir. [ Time Frame: multiple dose pravastatin (4 days) ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Genetic Predictors of Variability in the Drug-Drug Interaction Between Darunavir/Ritonavir and Pravastatin |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
- HIV Infections
- Hyperlipidemia
|
| Drug: Pravastatin, darunavir, ritonavir |
| |
| |
| |
| Recruiting |
| 36 |
| July 2009 |
| March 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 60 Years |
| Yes |
|
|
| United States |
| |
| NCT00630734 |
| Christina Aquilante, Pharm.D., University of Colorado Denver and Health Sciences Center |
| COMIRB07-0272, TMC114HIV4003 |
| University of Colorado at Denver and Health Sciences Center |
| Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA |
| Principal Investigator: |
Christina L Aquilante, PharmD |
University of Colorado Denver and Health Sciences Center |
|
|
| University of Colorado at Denver and Health Sciences Center |
| February 2008 |
