A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects

NCT00743470 | Terminated Phase 1

• 1 other identifier: M10-457
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Tuberculosis

Keywords

HIV co-infected with tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

A, B

EXPERIMENTAL

Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.

Drug: lopinavir/ritonavir; Drug: rifabutin

C

EXPERIMENTAL

Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.

Drug: lopinavir/ritonavir; Drug: rifabutin

Interventions

lopinavir/ritonavir DRUG

lopinavir/ritonavir tablet; see arm for intervention description

Also known as: ABT-378, Kaletra

A, B; C

rifabutin DRUG

rifabutin capsule; see arms for intervention description

A, B; C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 11441

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Lopinavir; lopinavir-ritonavir drug combination; Rifabutin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Angela Nilius, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2008
• Last Updated: November 2, 2010

Record last verified: 2010-09

Locations

US (1)