Condition category
Infections and Infestations
Date applied
04/08/2010
Date assigned
12/11/2010
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The human immunodeficiency virus (HIV) is a type of virus known as a retrovirus. HIV attacks and weakens the immune system, making it more difficult for a sufferer to fight infections. It is a highly contagious disease, through bodily fluids such as blood, semen and vaginal fluids. There is currently no cure for HIV, but there are a range of drug treatments that can allow people who are HIV positive to lead a long and full life. Antiretroviral therapy (ART) is the standard treatment for HIV, where at least three different antiretroviral (ARV) drugs are given at the same time. This treatment is very effective at suppressing the virus and stopping the development of the disease. When a person has been on ART, the amount of HIV present in the blood (viral load) is reduced. After three to six months of treatment, the viral load should have fallen to undetectable levels (undetectable viral load). A commonly used ART is Atripla, which contains the three drugs efavirenz, emtricitabine, and tenofovir. Although this treatment can be very effective, it can cause long-term health problems, specifically problems with the bones and kidneys. A possible reason for this is the Atripla treatment could lead to reduced levels of different vitamins and minerals in the body, such as vitamin D and calcium, which can affect hormone levels. The aim of this study is to find out if treating HIV patients with the ARV’s Darunavir/Ritonavir only (single-drug therapy) is less toxic for bones and kidneys than standard ART.

Who can participate?
HIV positive adults, currently taking Atripla, who have had an undetectable viral load in the last 6 months.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue their Aripla therapy, which involves taking the Atripla tablets (which contain efavirenz, emtricitabine, and tenofovir) daily for the 48 week study. Those in the second group stop taking their Aripla and take darunavir 800mg/ritonavir 100mg every day for 48 weeks. At the start of the study and then every month until 48 weeks, participants provide blood and urine samples in order to test kidney function and biomarkers (chemical indicators) of bone health.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
St. Thomas’ Hosptial (UK)

When is the study starting and how long is it expected to run for?
October 2010 to October 2013

Who is funding the study?
Tibotec (Janssen-Cilag Ltd) (UK)

Who is the main contact?
Dr Julie Fox

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julie Fox

ORCID ID

Contact details

Harrison Wing
St. Thomas' Hospital
2nd Floor Lambeth Wing
Westminster Bridge Road
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

JF-001

Study information

Scientific title

The metabolic impact of darunavir/ritonavir maintenance monotherapy after successful viral suppression with standard Atripla in HIV-1 infected patients: an unblinded, multicentre, randomised controlled trial

Acronym

MIDAs

Study hypothesis

This project aims to assess the potential long-term advantages of switching HIV patients from the standard therapy (Atripla) to a different regimen of treatment (darunavir 800 mg/ritonavir 100 mg) in terms of Vitamin D levels, calcium and phosphate homeostasis, renal (tubular) function, bone turnover and bone mineralisation and infection disease progression.

On 07/05/2014 the anticipated start date was changed from 01/03/2012 to 01/10/2014.

Ethics approval

Central London Research Ethics Committee 4, 04/08/2010

Study design

Multicentre open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

HIV

Intervention

At baseline, patients will be randomised to receive either
1. Darunavir 800mg/ritonavir 100mg daily
2. Atripla® daily
Study medication/HIV regimen will be dispensed at each study visit.

All participants will have the opportunity to discuss continuing their study drug with their routine clinician at study end.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Change in 25(OH)Vitamin D

Secondary outcome measures

1. Reduction in parathyroid hormone levels
2. Improvements in serum calcium, phosphate, alkaline phosphatase
3. Improvement in estimated glomerular filtration rate, albuminuria and proteinuria, tubular phosphate reabsorption and other markers of renal tubular dysfunction
4. Improvement in bone mineral density
5. Immune activation: change in immune activation (CD8+CD38+)
6. The proportion of participants without therapeutic failure (defined as two consecutive HIV-RNA values > 50 copies/ml)

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.

Overall trial start date

01/10/2010

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant 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

Recruitment start date

01/10/2010

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St. Thomas' Hospital
Harrison Wing 2nd Floor Lambeth Wing Westminster Bridge Road
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Guy's & St. Thomas' NHS Foundation Trust (UK)

Sponsor details

16th Floor
Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Tibotec (Janssen-Cilag Ltd) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/01/2016: No publications found, verifying study status with principal investigator.