A phase IV, two-arm, open-label, single-centre randomised pilot study to assess the feasibility of immeidate or deferred switching of HIV-infected individuals intolerant of efavirenz, ritonavir-boosted lopinavir or ritonavir-boosted atazanavir, to ritonavir-boosted darunavir - NNRTI/PI toxicity switch to darunavir study

• Conditions: HIV

• Registration Number: EUCTR2008-000604-88-GB
• Lead Sponsor: St Stephen's Aids Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

A subject will be eligible for inclusion in the study only if ALL of the following criteria apply:
•HIV-1 infected as documented by a licensed HIV-1 antibody ELISA test
•The subject is currently on an antiretroviral regimen comprising at least three licensed antiretroviral agents including efavirenz, ritonavir-boosted lopinavir or ritonavir-boosted atazanavir
•Symptomatic toxicity associated with the NNRTI/PI after at least 12 weeks of therapy
•The subject is virologically suppressed with a viral load < 50 copies/ml
•The subject has a CD4+ count above 50 cells/ml
•If the subject is a woman of child bearing potential, she must agree to use a barrier method of contraception
•No previous exposure to Darunavir

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

A subject will be eligible for inclusion in the study only if NONE of the following criteria apply:
1.Pregnant or lactating women
2.Any female subject of childbearing potential not using effective birth control methods or not 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: Hormone-based contraception may not be reliable when taking investigational agents; therefore, to be eligible for this trial, women of childbearing potential should either:
?Use a double barrier method to prevent pregnancy (i.e., using a condom with either spermicidal cream/foam/gel or diaphragm or cervical cap);
OR
?Use hormone-based contraceptive in combination with a barrier contraceptive (i.e. male condom, diaphragm, or cervical cap with spermicide),
OR
?Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm, or cervical cap with spermicide),
OR
?Do not engage in heterosexual sex, or have a vasectomised partner with confirmed sterility
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

Note: Spermicides containing non-oxynol-9 should not be used as this can potentially increase the rate of HIV-1 transmission

Note: Use of an IUD can increase the risk of sexually transmitted infections, including HIV

3.Heterosexually active male subject not using effective birth control methods or not willing to continue practising these birth control methods during the trial and until 30 days after the end of the trial (or after last intake of investigational ARVs)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether switching individuals intolerant to NNRTI/PI, to ritonavir boosted darunavir is associated with resolution of toxicity;Secondary Objective: •To investigate the change in CD4 count in individuals switching from NNRTI/PI to ritonavir boosted darunavir <br>•To investigate continued virological suppression at levels of < 400 copies /ml and 50 copies /ml in individuals switching from NNRTI/PI to ritonavir boosted darunavir <br>•To investigate changes in quality of life in individuals switching from NNRTI/PI to ritonavir boosted darunavir<br>•To investigate changes in fasting lipids-cholesterol and triglycerides- in individuals switching from NNRTI/PI to ritonavir boosted darunavir<br>•To investigate the impact of switching on adherence <br>•To investigate the impact of switching on patient-perceived distress associated with tolerability issues <br>;Primary end point(s): The improvement of NNRTI/PI associated toxicity after 4 weeks of therapy with ritonavir boosted darunavir