Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
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ClinicalTrials.gov Identifier: NCT00925535 |
Recruitment Status
:
Completed
First Posted
: June 22, 2009
Last Update Posted
: September 21, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: Lersivirine Drug: Rifabutin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (UK-453,061) In Healthy Subjects |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Treatment A
Lersivirine
|
Drug: Lersivirine
1000 mg once daily for 10 days
|
Active Comparator: Treatment B
Rifabutin
|
Drug: Rifabutin
300 mg once daily for 10 days
|
Experimental: Treatment C
Lersivirine and Rifabutin
|
Drug: Lersivirine
1000 mg once daily for 10 days
Drug: Rifabutin
300 mg once daily for 10 days
|
- Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ]
- Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ]
- Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments [ Time Frame: 58 days ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Hypersensitivity/allergic reactions to any component of the study drugs.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925535
Singapore | |
Pfizer Investigational Site | |
Singapore, Singapore, 188770 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00925535 History of Changes |
Other Study ID Numbers: |
A5271043 |
First Posted: | June 22, 2009 Key Record Dates |
Last Update Posted: | September 21, 2010 |
Last Verified: | September 2010 |
Keywords provided by Pfizer:
Pharmacokinetics HIV Tuberculosis Lersivirine UK-453 061 Rifabutin HIV Infections |
Additional relevant MeSH terms:
Rifabutin Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antitubercular Antitubercular Agents |