A phase III, open-label, single centre, single-arm, pilot study to assess the feasibility of switching, individuals receiving efavirenz with continuing Central Nervous System (CNS) toxicity, to raltegravir - Atripla toxicity switch to raltegravir study

Phase 1

• Conditions: HIV

• Registration Number: EUCTR2010-018878-21-GB
• Lead Sponsor: St Stephen's AIDS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Male or female aged 18 years or above
has a documented HIV-1 infection
has signed the Informed Consent Form voluntarily
is willing to comply with the protocol requirements
has an HIV-plasma viral load at screening <50 copies/mL
has a CD4 cell count at Screening >50 cells/mm3
has been on a stable ART, with at least 3 licensed agents, one of which being EFV, for at least 12 weeks at Screening, and has been on Atripla for at least 4 weeks at screening; the subject must be willing to stay on treatment until Baseline
estimated glomerular filtration rate (by MDRD or CG methods) >50 ml/min.
has symptomatic toxicity associated with EFV after at least 12 weeks of therapy
if female and of childbearing potential, she is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs);
Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
if a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

is infected with HIV-2
is using any concomitant therapy disallowed as per SPC for the study drugs
has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions (must be discussed with the sponsor prior to enrolment):
?Stable cutaneous Kaposi’s Sarcoma (no pulmonary or gastrointestinal involvement other than oral lesions) unlikely to require systemic therapy during the trial period
?CD4 count less than 200 cells/mm3
Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed
has acute viral hepatitis including, but not limited to, A, B, or C
has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN
Note: Subjects co-infected with chronic HBV or HCV can enter the trial if clinically stable and not expected to require treatment during the trial period.
has received any investigational drug within 30 days prior to the trial drug administration
Prior exposure to raltegravir or investigational integrase inhibitors
Any tenofovir or emtricitabine associated resistance mutations
No baseline resistance test available
Clinically significant allergy or hypersensitivity to any trial medication excipients
If female, she is pregnant or breastfeeding
screening blood results with any grade 3 / 4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
Clinical or laboratory evidence of significantly decreased hepatic function or decompensation: INR > 1.5 or albumin < 30g/L or bilirubin > 2.5 x ULN
Resolution of their CNS toxicity between Screening and Baseline visits
Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified