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

HIV Clinical Trial

Official title:

A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00743470
• Other study ID #: M10-457
• Status: Terminated
• Phase: Phase 1
• First received: August 27, 2008
• Last updated: October 29, 2010
• Start date: August 2008

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Tuberculosis

Intervention

Drug:
• lopinavir/ritonavir
lopinavir/ritonavir tablet; see arm for intervention description
• rifabutin
rifabutin capsule; see arms for intervention description

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 11441	Waukegan	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.		Approximately 0.5 - 1 month	No
Primary	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	Yes