Trial record 18 of 38 for:    " June 11, 2008":" July 11, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

VENICE Study Nevirapine Full Dose/Dose Escalation

This study has been completed.
Sponsor:
Information provided by:
Clinical Trial Agency of HIV Study Group
ClinicalTrials.gov Identifier:
NCT00704249
First received: June 22, 2008
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

This study aims to compare the trough plasma concentrations of nevirapine after 7 days of treatment at the full dose from baseline with dose escalation in patients taking efavirenz who switch to nevirapine due to neuropsychiatric adverse reactions.


Condition Intervention Phase
HIV Infections
Drug: nevirapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized Multicenter Study to Compare Starting Nevirapine at the Full Dose With Dose Escalation in Patients Who Require Efavirenz to be Withdrawn Due to Adverse Reactions

Resource links provided by NLM:


Further study details as provided by Clinical Trial Agency of HIV Study Group:

Primary Outcome Measures:
  • The proportion of patients with a trough concentration of nevirapine in plasma within the therapeutic range (3000 to 8000 ng/mL) after 7 days of treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients with a plasma viral load of less than 50 copies/mL will be obtained. The change in CD4+ T-cell count will also be measured from baseline to weeks 4 and 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients who experience adverse events (proportion of patients with exanthema and proportion of patients with liver toxicity) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients with resolution of the neuropsychiatric adverse reaction to efavirenz that led to it being withdrawn [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: July 2006
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Full-dose nevirapine from baseline (200 mg bid).
Drug: nevirapine
Full-dose nevirapine from baseline (200 mg bid).
Active Comparator: 2
Nevirapine with an increase in the initial dose (200 mg once daily for 14 days and 200 mg bid thereafter)
Drug: nevirapine
Nevirapine with an increase in the initial dose (200 mg once daily for 14 days and 200 mg bid thereafter)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ³ 18 years
  • Chronic HIV-1 infection confirmed by Western blotting
  • Patients treated with a HAART regimen containing efavirenz for a minimum of 15 days before the baseline visit
  • Patients who present a neuropsychiatric adverse reaction to efavirenz (see list in Appendix D) and require it to be withdrawn.
  • Ability of the patient to follow treatment during the period established
  • Acceptance and signing of the informed consent document

Exclusion Criteria:

  • Liver function test (AST, ALT, GGT) results > 3 times the upper limit of normal.
  • Elevated creatinine levels (>1.5 mg/dL)
  • CD4+ T-cell count > 400 cells/µL in men or > 250 cells/µL in women, unless the benefit outweighs the risk (warning in the summary of product characteristics) and always at the investigator's discretion
  • HIV plasma viral load > 50 copies/mL in those patients who have been taking efavirenz for more than 3 months
  • Suspected or confirmed resistance to efavirenz and/or nevirapine
  • Patients who are currently taking a drug that might interfere in the absorption, distribution, or metabolism of nevirapine
  • Presence of opportunistic infections and/or neoplasm during the 3 months before the start of participation in the trial
  • Any medical condition(s) that, in the investigator's opinion, might interfere with the patient's ability to participate or fulfill the requirements of the present protocol
  • Pregnancy
  • Suspected primary infection of less than 6 months' duration
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704249

Locations
Spain
Hospital General de Elche
Elche, Alicante, Spain
Hospital Germanas Trias i Pujol
Badalona, Barcelona, Spain
Hospital General de Granollers
Granollers, Barcelona, Spain, 08400
Hospital Príncipe de Asturias
Alcala de Henares, Madrid, Spain, 28880
Hospital General Alicante
Alicante, Spain
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu y Sant Pau
Barcelona, Spain, 08025
Hospital Vall d´Hebrón
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital Provincial Reina Sofía de Córdoba
Cordoba, Spain, 14004
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital La Paz
Madrid, Spain, 28046
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Virgen de la Victoria
Malaga, Spain, 29010
Sponsors and Collaborators
Clinical Trial Agency of HIV Study Group
Investigators
Study Chair: Esteban Ribera Clinical Trial Agency of HIV Study Group
  More Information

No publications provided

Responsible Party: Esteban Ribera, Clinical Trial Agency of HIV Study Group
ClinicalTrials.gov Identifier: NCT00704249     History of Changes
Other Study ID Numbers: GESIDA-4905
Study First Received: June 22, 2008
Last Updated: February 10, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Clinical Trial Agency of HIV Study Group:
HIV infection
nevirapine
Treatment Experienced

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
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

ClinicalTrials.gov processed this record on August 18, 2014