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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02184078
First received: July 8, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Nevirapine
Drug: Rifabutin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study in HIV+ Patients to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Cmax,ss (maximum observed concentration at steady state) [ Time Frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42 ] [ Designated as safety issue: No ]
  • Cmin,ss (minimum observed concentration at steady state) [ Time Frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42 ] [ Designated as safety issue: No ]
  • Tmax,ss (Time of Cmax at steady state) [ Time Frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration time curve over the dosing interval [ Time Frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42 ] [ Designated as safety issue: No ]
  • CL/F (apparent total clearance) [ Time Frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patient with adverse events [ Time Frame: up to day 43 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: October 1998
Primary Completion Date: December 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single group

Nevirapine:

Study days 15-28 dose given once a day (q.d.) Study days 29-42 dose given twice a day (b.i.d.)

Rifabutin:

Study Days 0 to 42

Drug: Nevirapine Drug: Rifabutin

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02184078     History of Changes
Other Study ID Numbers: 1100.1258
Study First Received: July 8, 2014
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Rifabutin
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014