Metabolic Impact of Darunavir monotherapy vs Atripla in HIV patients

Phase 4

Completed

• Conditions: HIV; Infections and Infestations; Unspecified human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN11504121
• Lead Sponsor: Guy's & St. Thomas' NHS Foundation Trust (UK)

Brief Summary

1. 2016 results of the effects on vitamin D, bone and the kidney when switching from fixed-dose tenofovir disoproxil fumarate/emtricitabine/efavirenz to darunavir/ritonavir monotherapy, in https://www.ncbi.nlm.nih.gov/pubmed/26460504 (added 21/01/2019) 2. 2016 results of switching from Atripla to darunavir/ritonavir Monotherapy on neurocognition, quality of life, and sleep, in https://www.ncbi.nlm.nih.gov/pubmed/27216134 (added 21/01/2019) 3. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27898597 (added 21/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-12
• Study Completion: 2014-10-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Between 18-65 Males and Females
2. Documented Positive HIV-antibody test and previous positive HIV-antibody test within three months of the start of the study
3. Plasma HIV RNA <50 copies/ml for at least six months on Atripla
4. Agree to NOT take vitamin D supplements for the duration of the study
5. Willing to use barrier contraception (condoms) for the duration of their participation in the study
6. Ability to give informed consent

Exclusion Criteria

1. Pregnancy or breast feeding
2. Patient unlikely to comply with protocol, and in particular adhere to therapeutic regimen
3. Patient likely to use narcotics during the study period
4. Hepatitis B co-infection (past or present)
5. Diabetes mellitus
6. Received vitamin D supplementation for more than one month within the previous 6 months
7. Current use or likely to require use of concomitant medication with known interactions with Darunavir or Ritonavir including rifampicin, amiodarone, flecainide, bupropion, clozapine, ergotamine, mexilitine, midazolam, pethidine, pimoziide, quinidine, sertindole, sildanefil, voriconazole, zolpidem, and St. John?s Wort would exclude a subject from the trial
8. Individuals experiencing side effects from their current regime will not be excluded from analysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 25(OH)Vitamin D

Secondary Outcome Measures

Name	Time	Method
<br> 1. Reduction in parathyroid hormone levels<br> 2. Improvements in serum calcium, phosphate, alkaline phosphatase<br> 3. Improvement in estimated glomerular filtration rate, albuminuria and proteinuria, tubular phosphate reabsorption and other markers of renal tubular dysfunction<br> 4. Improvement in bone mineral density<br> 5. Immune activation: change in immune activation (CD8+CD38+)<br> 6. The proportion of participants without therapeutic failure (defined as two consecutive HIV-RNA values > 50 copies/ml)<br><br> Outcomes will be measured throughout the study period though lab analysis will be carried out at end of the study. Samples will be blood/urine samples and for substudy, genital secretions.<br>