Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage
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Purpose
Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.
Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage.
Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs.
The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infection HIV Infection |
Drug: Efavirenz |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blinded Clinical Trial to Evaluate the Incidence and Severity of Neuropsychiatric Side Effects and Antiviral Efficacy of Efavirenz Given as a Stepped Dosage Over 2 Weeks Versus the Usual Dosage in HIV-Infected Patients. |
- incidence and severity of neuropsychiatric side effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Virological efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 114 |
| Study Start Date: | April 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: B |
Drug: Efavirenz
Efavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward) OR Efavirenz usual dosage (600 mg/day from the first day) |
| Experimental: A |
Drug: Efavirenz
Efavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward) OR Efavirenz usual dosage (600 mg/day from the first day) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age older than 18 years
- HIV-1 infection
- Women of child-bearing age: negative pregnancy test
- Ability to understand and sign a written consent form
Exclusion Criteria:
- Pregnancy..
- Illegal drug or methadone use.
- Major psychiatric disease antecedents or starting new psychotropic agents in the last 4 weeks
- Concomitant treatment with rifamycins, protease inhibitors or drugs which interfere the pharmacokinetic of efavirenz.
- Hepatic insufficiency
Contacts and Locations| Spain | |
| Hospital de Jerez | |
| Jerez de la Frontera, Cadiz, Spain | |
| Hospital Torrecardenas | |
| Almeria, Spain | |
| Hospital Universitario Puerta del Mar | |
| Cadiz, Spain | |
| Hospital Universitario Reina Sofía | |
| Cordoba, Spain | |
| Hospital Juan Ramon Jimenez | |
| Huelva, Spain | |
| Hospital Universitario Virgen de la Victoria | |
| Malaga, Spain | |
| Hospital Universitario Carlos Haya | |
| Malaga, Spain | |
| Hospital Universitario de Valme | |
| Seville, Spain | |
| Hospital Universitario Virgen Macarena | |
| Seville, Spain | |
| Hospitales Universitarios Virgen del Rocio | |
| Seville, Spain, 41013 | |
| Study Director: | Luis F Lopez-Cortes, MD, PhD | Hospitales Universitarios Virgen del Rocio. Seville. Spain |
More Information
No publications provided by Sociedad Andaluza de Enfermedades Infecciosas
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Luis Fernando Lopez-Cortes, Servicio Andaluz de Salud. Hospitales Uiversitarios Virgen del Rocíoi |
| ClinicalTrials.gov Identifier: | NCT00556634 History of Changes |
| Other Study ID Numbers: | SAEI_EFV |
| Study First Received: | November 8, 2007 |
| Last Updated: | January 14, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas:
|
HIV efavirenz central nervous system adverse effects |
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 |
Efavirenz 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 May 23, 2013