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

NCT02184299 | Completed Phase 4

• 1 other identifier: 1100.1286
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Incidence of rash

  up to 42 days after initiation of nevirapine

Secondary Outcomes (4)

• Severity of rash

  up to 42 days after initiation of nevirapine

• Change in Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) count

  up to 24 weeks

• Number of patients with adverse events

  up to 198 days

• Change in Lymphocytes expressing CD4+ Surface Marker (CD4+) count

  up to 24 weeks

Study Arms (2)

Nevirapine + Prednisone

EXPERIMENTAL

week 1-2: Nevirapine + Prednisone week 3-24: Nevirapine alone

Drug: Nevirapine; Drug: Prednisone

Nevirapine

ACTIVE COMPARATOR

week 1-24: Nevirapine

Drug: Nevirapine

Interventions

Nevirapine DRUG

Nevirapine; Nevirapine + Prednisone

Prednisone DRUG

Nevirapine + Prednisone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine; Prednisone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 9, 2014
• Study Start: April 1, 1999
• Primary Completion: January 1, 2000
• Last Updated: July 14, 2014

Record last verified: 2014-07