Study of Nevirapine and Prednisone to Determine the Safety and Effectiveness in Preventing Nevirapine Associated Rash in Human Immunodeficiency Virus (HIV) Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02184299
First received: July 8, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

Study to determine the incidence of rash between the group receiving nevirapine without prednisone and the group receiving nevirapine with prednisone


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, Controlled Study of Nevirapine (VIRAMUNE®) and a Short Course of Prednisone to Determine the Safety and Effectiveness of This Strategy in Preventing Nevirapine (VIRAMUNE®) Associated Rash.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of rash [ Time Frame: up to 42 days after initiation of nevirapine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of rash [ Time Frame: up to 42 days after initiation of nevirapine ] [ Designated as safety issue: No ]
  • Change in Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) count [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to 198 days ] [ Designated as safety issue: No ]
  • Change in Lymphocytes expressing CD4+ Surface Marker (CD4+) count [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: April 1999
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nevirapine + Prednisone

week 1-2: Nevirapine + Prednisone

week 3-24: Nevirapine alone

Drug: Nevirapine Drug: Prednisone
Active Comparator: Nevirapine
week 1-24: Nevirapine
Drug: Nevirapine

  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 of any ethnic group between the ages of 18 and 65 years of age

    • Women of childbearing potential had to utilize adequate birth control to prevent pregnancy for study duration. Due to possibility that study drugs could alter the effectiveness of oral contraceptives or depo-progesterone, oral contraceptives or depo-progesterone were not to be used as the sole form of birth control for the duration of this study
    • Women of childbearing potential had to have a negative serum human chorionic gonadotropin (b-hCG) within 14 days prior to initiation of study therapy
  • Presence of HIV-1 infection as documented by any licensed Enzyme-Linked Immunosorbent Assay (ELISA) test kit and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry
  • A CD4+ cell count of 100 cells/mm³ documented within 30 days of baseline visit. If a patient had a history of a clinical AIDS defining event, i.e. Pneumocystis carinii pneumonia (PCP), Kaposi sarcoma, etc, his/her CD4+ cell count had to be >= 200 cells/mm³
  • Patients could have either a) no prior antiretroviral therapy or b) prior antiretroviral therapy but no Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) therapy. Antiretroviral experienced patients eligible to enroll in this study were patients who had any of the following characteristics

    • Switching Patients: Patients with two consecutive ultra-sensitive HIV-RNA assay results below the limit of quantification (BLQ) at least one week apart
    • Patients Optimizing Therapy: Patients who had responded with substantial drops in HIV-RNA counts without reaching BLQ or patients who had failed their current regimen and needed to change to a new drug regimen
    • Patients Re-starting Therapy: Patients who were antiretroviral experienced but had not received antiretroviral therapy in the previous three months before enrolling in this study All antiretroviral experienced patients had to have been on a stable regimen or for at least three months immediately prior to their enrollment or they had to have been on no antiretroviral therapy for at least three months immediately prior to their enrollment
  • Ability and willingness to give written informed consent and comply with study requirements
  • Patients must have had an ambulatory performance score of >= 80 on the Karnofsky scale

Exclusion Criteria:

  • Female patients who were pregnant or breast-feeding
  • Patients with an acute and/or active AIDS defining illness
  • History of any illness or drug allergy that in the opinion of the Investigator could confound the results of the study or pose additional risk in administering nevirapine to the patient
  • Patients with active invasive infections including pneumonia, septicemia, meningitis and encephalitis; not including upper respiratory infections, dermatologic infection, oral infection and urinary tract infection
  • Patients who where currently taking any prescription or non-prescription drug that in the opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals Incorporated (BIPI) medical monitor could interfere with either the absorption, distribution or metabolism of nevirapine or prednisone
  • The following laboratory parameters documented within 30 days prior to baseline visit:

    • Hemoglobin < 9.1 g/dL for men; < 8.9 g/dL for women
    • Absolute neutrophil counts < 750 cells/mm³
    • Platelet counts < 50000 platelets/mm³
    • AST (SGOT)/ALT (SGPT) > five times upper limit of normal range (ULN)
    • Creatinine > two times ULN
  • Documented or suspected acute hepatitis within 30 days prior to baseline visit irrespective of Aspartate Aminotransferase (AST) Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Alanine Aminotransferase (ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) values that were five times ULN
  • Unexplained temperature > 38.5 °C for any seven days or chronic diarrhea defined as more than three stools per day that persisted for 15 days within 30 days prior to baseline visit
  • History of illnesses that contraindicated the use of prednisone such as hypertension, diabetes and diseases of the adreno-pituitary axis. Any chronic gastrointestinal conditions that could interfere with study drug absorption
  • Receipt of the following

    • Any NNRTI therapy at anytime prior to baseline visit
    • Interferons, interleukins or any vaccine including HIV vaccine within 30 days prior to baseline visit
    • Any investigational agents that needed to be continued during the study
    • Abacavir
    • Patients who would be taking known inhibitors or inducers of P450 metabolic enzymes including ketoconazole, itraconazole, rifampin and phenytoin were not enrolled. In addition the following drugs were not allowed during the study: cytochrome P450 3A4 substrates such a terfenadine, astemizole, cisapride, triazolam and midazolam. Non-nucleoside reverse transcriptase inhibitors other than study-provided nevirapine were not allowed
  • The presence of skin rash or mucosal lesions that in the opinion of the Investigator could compromise the wellbeing of the patient or confound that assessment of a nevirapine-associated rash. Localized skin rashes (e.g. facial folliculitis or contact dermatitis) were not to be the only basis for exclusion from this trial
  • Presence of occult (microscopic) or frank (macroscopic) blood in the stools
  • Any medical condition which in the opinion of the Investigators would interfere with the patient's ability to participate in or adhere to the requirements of this protocol
  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: NCT02184299     History of Changes
Other Study ID Numbers: 1100.1286
Study First Received: July 8, 2014
Last Updated: July 11, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Public Health Agency of Canada
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
Prednisone
Nevirapine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 29, 2014