Phase 1
Completed N=33
Drug Interaction Study
Antivirals/HIV
Source: ClinicalTrials.gov NCT00646776 ↗
Enrolled (actual)
33
Serious AEs
6.1%
Results posted
Jan 2011
Primary outcomePrimary: Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB) — 1565; 2311 nanograms*hour /milliliters (ng*h/mL)
Summary
The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB) |
1565; 2311 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of RIB |
159.0; 395.6 | — |
| PRIMARY Minimum Plasma Concentration (Cmin) of RIB |
28.89; 40.49 | — |
| PRIMARY AUC24avg for 25-O-Desacetyl-RIB |
117.7; 1283 | — |
| PRIMARY Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB) |
13.44; 104.36 | — |
| PRIMARY Cmin of 25-O-Desacetyl-RIB |
2.79; 31.97 | — |
| PRIMARY Total Area Under the Plasma Concentration-time Curve (AUCtot) |
2.00; 4.38 | — |
| SECONDARY Cmax of ATV |
5633 | — |
| SECONDARY Cmin of ATV |
920.69 | 0.0963 |
| SECONDARY AUC(TAU) for ATV |
51795 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV |
2.00 | — |
| SECONDARY Terminal Elimination Half-life (T-half) of ATV |
11.89 | — |
| SECONDARY Cmax of RTV |
1466 | — |
| SECONDARY Cmin of RTV |
40.54 | — |
| SECONDARY AUC(TAU) for RTV |
8699 | — |
| SECONDARY Tmax of RTV |
4.00 | — |
| SECONDARY T-half of RTV |
4.45 | — |
| SECONDARY Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation. |
0; 0; 0; 2; 5; 13 | — |
| SECONDARY Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes |
0; 1; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) |
1; 10; 1; 5; 0; 0 | — |
| SECONDARY Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With MAs in Urinalysis |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Identified Electrocardiogram (ECG) Abnormalities |
0; 3 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (BMI) of 18 to 32 kg/m²
- Prior to enrollment, subjects must have physical and laboratory test findings within the normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test
Exclusion Criteria
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
- Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
- Use of any other drugs, including over-the-counter medications of herbal preparations within 1 week prior to study drug administration
Data sourced from ClinicalTrials.gov (NCT00646776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.