VENICE Study Nevirapine Full Dose/Dose Escalation

NCT00704249 | Completed Phase 4

• 1 other identifier: GESIDA-4905
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 15

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.

Conditions

HIV Infections

Keywords

HIV infection; nevirapine; Treatment Experienced

Outcome Measures

Primary Outcomes (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.

  7 days

Secondary Outcomes (3)

• 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.

  12 weeks

• The proportion of patients who experience adverse events (proportion of patients with exanthema and proportion of patients with liver toxicity)

  4 weeks

• Proportion of patients with resolution of the neuropsychiatric adverse reaction to efavirenz that led to it being withdrawn

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Full-dose nevirapine from baseline (200 mg bid).

Drug: nevirapine

2

ACTIVE COMPARATOR

Nevirapine with an increase in the initial dose (200 mg once daily for 14 days and 200 mg bid thereafter)

Drug: nevirapine

Interventions

nevirapine DRUG

Full-dose nevirapine from baseline (200 mg bid).

1

Eligibility Criteria

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

You may qualify if:

• 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• Patients who present a neuropsychiatric adverse reaction to efavirenz (see list in Appendix D) and require it to be withdrawn.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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Trial Agency of HIV Study Group: lead

Study Sites (15)

Hospital General Alicante

Alicante, Alicante, Spain

Location

Hospital General de Elche

Elche, Alicante, Spain

Location

Hospital Germanas Trias i Pujol

Badalona, Barcelona, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Santa Creu y Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinic

Barcelona, Barcelona, Spain

Location

Hospital Vall d´Hebrón

Barcelona, Barcelona, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08400, Spain

Location

Hospital Provincial Reina Sofía de Córdoba

Córdoba, Cordoba, 14004, Spain

Location

Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, 28880, Spain

Location

Hospital de la Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Virgen de la Victoria

Málaga, Malaga, 29010, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

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

Study Officials

• Esteban Ribera

  Clinical Trial Agency of HIV Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2008
• First Posted: June 24, 2008
• Study Start: July 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 11, 2009

Record last verified: 2009-02

Locations

ES (15)