Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: Nevirapine

Drug: Rifabutin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02184078

1100.1258

Details and patient eligibility

About

Study to determine the effects of nevirapine on the steady state pharmacokinetics of rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in combination with rifabutin

Enrollment

19 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients between the ages of 18 and 65 years who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method e.g. Western Blot
Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) >= 100 cells/mm³
Patients must be taking at least 2 antiretroviral agents (with the exception of ritonavir, nelfinavir and non-nucleoside reverse transcriptase inhibitors taken continuously for at least 28 days prior to study entry (Day 0)
Patients currently being treated with rifabutin during the screening period may be included provided that patients are receiving 300 mg once daily (or 150 mg once daily for patients concomitantly taking Zidovudine (ZDV), saquinavir or indinavir) and that there has been no change in dosing of > 25% within 28 days prior to Study Day 0
Patients who meet the following laboratory parameter:
- Granulocyte count > 1000 cells/mm³
- Hemoglobin > 9.0 g/dl (men and women)
- Platelet count > 75000 cells/mm3
- Alkaline Phosphatase < 3.0 times the upper limit of normal
- Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) < 3.0 times the upper limit of normal
- Total bilirubin < 1.5 times the upper limit of normal
Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically form of barrier contraception
Patients able to provide written consent and comply with study requirements

Exclusion criteria

Female patients who are pregnant or breast-feeding
Seated systolic blood pressure below 100 mmHg or greater than 150 mmHg and/or heart rate less than 50 or greater than 90 beats/min.
History of drug allergy or known drug hypersensitivity
Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of study entry (Study Day 0). Such substances in theses categories include: macrolide antibiotics (erythromycin, clarithromycin, azithromycin) azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin and phenytoin
Use of ritonavir, nelfinavir or non-nucleoside reverse transcriptase inhibitors within 28 days of Study Day 0 or during the trial
Patients with clinical evidence of active tuberculosis (TB) or undergoing treatment or prophylaxis for TB
Patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year)
History of any clinically important disease including hepatic, renal, cardiovascular or gastrointestinal
Patients with malabsorption, severe chronic diarrhea or subject unable to maintain adequate oral intake
Patients with no previous antiretroviral background therapy taken continuously for the 28 days prior to study entry (Day 0)