HIV, Tuberculosis
Conditions
Keywords
HIV co-infected with tuberculosis
Brief summary
The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.
Interventions
DRUGlopinavir/ritonavir
lopinavir/ritonavir tablet; see arm for intervention description
DRUGrifabutin
rifabutin capsule; see arms for intervention description
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult Male or Female 18-55 yrs. * Subject has provided written consent. * Subject is in general good health. * If female, subject is postmenopausal. * If female, subject is not pregnant and is not breast-feeding. * Subject must use birth control methods or be surgically sterile.
Exclusion criteria
* Subject is HAV-IgM, HBsAg or HIV Ab positive. * Positive screen for drugs of abuse, alcohol, or smoking. * Cannot be on any medication, including over the counter drugs. * Cannot have previous history of alcohol or drug abuse. * Cannot have history of any major diseases or disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter. | Approximately 0.5 - 1 month |
| Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs. | Approximately 0.5 - 1 month |
Countries
United States
Outcome results
None listed