The impact of a new single therapy (Darunavir/ritonavir) on metabolism after successfully suppressing the virus with the normal treatment (Atripla) for HIV-1-infected patients (MIDAs).

Phase 1

Active, not recruiting

• Conditions: HIV; MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10020180Term: HIV positiveSystem Organ Class: 10022891 - Investigations; MedDRA version: 14.1Level: PTClassification code 10020188Term: HIV test positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2010-022120-72-GB
• Lead Sponsor: Guy's & St. Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-02
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Males and Females aged between 18 and 65
2.Documented Positive HIV 1-antibody test
3.Plasma HIV RNA <100 copies/ml and on Atripla for at least six months prior to study start
4.Agreeable NOT take vitamin D supplements for the duration of the study
5.Ability to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

•Pregnant or breast feeding
•Patient unlikely to comply with protocol, and in particular adhere to therapeutic regimen
•Hep B sAg positive at screening or prior to starting antiretroviral therapy (ARV)
•Known active HCV
•Documented hepatic impairment
•Major protease inhibitor mutations likely to significantly impact on the efficacy of darunavir/ritonavirDocumented osteoporosis requiring treatment
•Diabetes mellitus
•Received vitamin D supplementation within 3 months of screening visit.
•Women of childbearing potential, or sexually active males with female partners of childbearing potential unwilling to use barrier method contraception (condoms)
•Hypersensitivity to any of the active substances and excipients
•Current or likely use of any of the following substances would exclude an individual from the trial: rifampicin, antiarrhythmics (amiodarone, bepridil, encainide, flecanide, propafenone, quinidine, systemic lidocaine), alfuzosin, analgesics (Pethidine, piroxicam, propoxyphne),antihistamines (astemizole, terfenadine), Antibiotics (fusidic acid), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), antipsychotics/neuroleptics (Clozapine, pimozide, sertindole), sedatives/hypnotics (Clorazepate, diazepam, estazolam, flurazepam, triazolam and midazolam administered orally) and HMG-CoA reductase inhibitors (simvastatin and lovastatin), PDE5 inhibitor (Sildenafil), St. John’s Wort and/or any CYP3A inhibitors.
•Individuals experiencing side effects from their current regime will not be excluded from analysis.
•Documented HIV-2 antibody test

Study & Design

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