Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
NCT00925535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2010-09-21
Summary
Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Lersivirine
1000 mg once daily for 10 days
- DRUG
-
Rifabutin
300 mg once daily for 10 days
- DRUG
-
Lersivirine
1000 mg once daily for 10 days
- DRUG
-
Rifabutin
300 mg once daily for 10 days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2010-08-31
- Completion
- 2010-08-31
Countries
- Singapore
Study Locations
More Related Trials
-
A Study of LY2835219 in Healthy Participants
NCT02256267 ·Status: COMPLETED ·Phase: PHASE1
-
Trial of High-Dose Rifampin in Patients With TB
NCT01408914 ·Status: COMPLETED ·Phase: PHASE2
-
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
NCT00023361 ·Status: COMPLETED ·Phase: NA
-
Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV
NCT01601626 ·Status: TERMINATED ·Phase: PHASE2
-
Anti-tuberculosis (TB) Drug Levels and Correlation With Drug Induced Hepatotoxicity
NCT01456845 ·Status: COMPLETED
-
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
NCT03478033 ·Status: UNKNOWN ·Phase: NA
-
Randomized Clinical Trial Comparing 4RIF vs. 9INH for LTBI Treatment-effectiveness
NCT00931736 ·Status: COMPLETED ·Phase: PHASE3
-
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
NCT03474029 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
NCT04930744 ·Status: COMPLETED ·Phase: PHASE2
-
Phenotyping of High Dose Rifampicin
NCT04525235 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
NCT01231542 ·Status: COMPLETED ·Phase: PHASE1
-
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.
NCT00000796 ·Status: COMPLETED ·Phase: NA
-
2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB.
NCT03988933 ·Status: COMPLETED ·Phase: PHASE2
-
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
NCT00810407 ·Status: COMPLETED
-
The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB)
NCT02953847 ·Status: COMPLETED ·Phase: PHASE1
-
TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
NCT00023387 ·Status: COMPLETED ·Phase: NA
-
Shorter and Safer Treatment Regimens for Latent TB
NCT06498414 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Safety and Efficacy of High Dose Rifampicin in Tuberculosis (TB)-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy
NCT03982277 ·Status: COMPLETED ·Phase: PHASE2
-
Risk of SDRs Under 3HP and 1HP Regimen for LTBI
NCT04094012 ·Status: COMPLETED ·Phase: PHASE3
-
The Correlate of Risk Targeted Intervention Study
NCT02735590 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Study of Safety and Efficacy of Different Regimes of Reintroduction of Anti-TB Drugs in Anti-TB Drugs Induced Liver Damage
NCT00405301 ·Status: COMPLETED ·Phase: PHASE4
-
Tuberculosis Clinical Trials Consortium Study 35
NCT03730181 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Tolerability, Extended Early Bactericidal Activity and PK of Higher Doses Rifampicin in Adults With Pulmonary TB
NCT01392911 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing Two Preventive Regimens for Latent Tuberculosis Infection (LTBI)
NCT01398618 ·Status: UNKNOWN ·Phase: PHASE3
-
Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis
NCT04951986 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3