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VENICE Study Nevirapine Full Dose/Dose Escalation (VENICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00704249
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : February 11, 2009
Information provided by:
Clinical Trial Agency of HIV Study Group

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: nevirapine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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Study to Compare Starting Nevirapine at the Full Dose With Dose Escalation in Patients Who Require Efavirenz to be Withdrawn Due to Adverse Reactions
Study Start Date : July 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. The proportion of patients who experience adverse events (proportion of patients with exanthema and proportion of patients with liver toxicity) [ Time Frame: 4 weeks ]
  3. Proportion of patients with resolution of the neuropsychiatric adverse reaction to efavirenz that led to it being withdrawn [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00704249

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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 Clinic
Barcelona, Spain
Hospital Vall d´Hebrón
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 Ramón y Cajal
Madrid, Spain, 28034
Hospital La Paz
Madrid, Spain, 28046
Hospital Virgen de la Victoria
Malaga, Spain, 29010
Sponsors and Collaborators
Clinical Trial Agency of HIV Study Group
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Study Chair: Esteban Ribera Clinical Trial Agency of HIV Study Group

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Responsible Party: Esteban Ribera, Clinical Trial Agency of HIV Study Group Identifier: NCT00704249     History of Changes
Other Study ID Numbers: GESIDA-4905
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Keywords provided by Clinical Trial Agency of HIV Study Group:
HIV infection
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
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
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers