Condition category
Infections and Infestations
Date applied
02/04/2007
Date assigned
31/05/2007
Last edited
03/11/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Charles Gilks

ORCID ID

Contact details

Faculty of Medicine
Imperial College
Norfolk Place
London
W2 1PG
United Kingdom
dart@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SARA

Study hypothesis

The use of ritonavir-boosted lopinavir (as Aluvia® tablets) monotherapy is an important simplification approach for second-line antiretroviral therapy in resource-limited settings.

Ethics approval

1. Medicines Control Authority of Zimbabwe (MCAZ). Date of approval: 06/06/2007 (ref: B279/5/67/2007)
2. Medical Research Council of Zimbabwe (MRCZ) Date of approval: 03/03/2007 (ref: MRCZ/A/1378)
3. Ugandan National Council for Science and Technology (UNCST) Date of approval: 20/06/2007 (ref: MV 710)
4. Ugandan Virus Research Institute (UVRI SEC) Date of approval: 20/04/2007 (ref: GC/127/04/07)

Study design

Three-centre open-label randomised pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

HIV/AIDS

Intervention

Comparison of two strategies for second-line antiretroviral therapy after 24 weeks of combination Aluvia® (or Kaletra®)-containing antiretroviral therapy:

Arm 1: Continued combination Aluvia-containing antiretroviral therapy
Arm 2: Maintenance with Aluvia monotherapy

The dose of Aluvia is 2 tablets twice a day (each tablet is 200 mg of lopinavir with 50 mg of ritonavir) for both arms. All drugs are taken orally.

Each patient will be randomized to one of the two arms on enrolment and start receiving the corresponding therapy until the end of the trial (September 2009). The randomization will be carried out in a 1:1 ratio.

Intervention type

Drug

Phase

Not Specified

Drug names

Lopinavir and ritonavir (Aluvia®/Kaletra®)

Primary outcome measures

1. Change in CD4 count at 24 weeks after randomisation (efficacy)
2. Any Serious Adverse Event (SAE), which is not HIV related only (safety)

Secondary outcome measures

1. Progression to a new or recurrent WHO stage 4 HIV event or death
2. Progression to a new or recurrent WHO stage 3 or 4 HIV event or death
3. Change in CD4 count from SARA randomisation to 48, 72 and 96 weeks
4. Any grade 3 or 4 adverse events
5. HIV RNA viral load (performed retrospectively) at 12, 24, 36, 48, 72 and 96 weeks
6. Adherence as measured by questionnaire and pill counts
7. Health economic outcomes

Overall trial start date

25/07/2007

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Enrolled in the DART trial (ISRCTN13968779 at http://www.controlled-trials.com/ISRCTN13968779)
2. Failed first-line antiretroviral therapy (clinically/immunologically) and having completed 24 weeks of second-line combination antiretroviral therapy including ritonavir-boosted lopinavir (as either Aluvia® heat-stable tablets or Kaletra® capsules)
3. Documented informed consent
4. Life expectancy of at least 3 months

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

240

Participant exclusion criteria

Pregnant or breast-feeding

Recruitment start date

25/07/2007

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Uganda, Zimbabwe

Trial participating centre

Faculty of Medicine
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Medical Research Council Clinical Trials Unit (UK)

Sponsor details

222 Euston Road
London
NW1 2DA
United Kingdom
dart@ctu.mrc.ac.uk

Sponsor type

Government

Website

http://www.ctu.mrc.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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