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Completed

NCT Number: NCT00630734

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Dyslipidemias Genital Diseases Hyperlipidemia Hyperlipidemias Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pravastatin

Drug

Pravastatin 40 mg by mouth daily on days 1-4

Other names: Pravachol

Darunavir

Drug

Darunavir 600mg by mouth twice daily on days 12-18

Other names: Prezista

Ritonavir

Drug

Ritonavir 100mg by mouth twice daily on days 12-18

Other names: Norvir

Washout

Other

Washout (no medication) on days 5-11.

Primary outcomes

  1. Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose

    AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.

  2. Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose

    Cmax of pravastatin when administered with darunavir/ritonavir divided by the Cmax of pravastatin when administered alone.

Secondary outcomes

  1. Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose

    Dosing interval of 24 hours

  2. Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose

  3. Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose

    Dosing interval of 24 hours

  4. Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose

Other outcomes

  1. Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval

    Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose

    AUC of darunavir over a 12-hour dosing interval.

  2. Darunavir Maximum Plasma Concentration (Cmax)

    Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose

    Cmax of darunavir over a 12-hour dosing interval

  3. Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval

    Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose

    AUC of ritonavir over a 12-hour dosing interval.

  4. Ritonavir Maximum Plasma Concentration (Cmax)

    Time frame: 0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dose

    Cmax of ritonavir over a 12-hour dosing interval

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Registry information

Official study title

Genetic Predictors of Pharmacokinetic Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin: the Role of SLCO1B1 Polymorphisms.

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 7, 2008
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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