Second-line Anti-Retroviral therapy in Africa: a randomised trial to evaluate the feasibility of maintenance monotherapy with ritonavir-boosted lopinavir (Aluvia® tablets) following initiation with 24 weeks of combination therapy in second-line anti-retroviral therapy in Africa

ISRCTN	ISRCTN53817258
DOI	https://doi.org/10.1186/ISRCTN53817258
Protocol serial number	N/A
Sponsor	Medical Research Council Clinical Trials Unit (UK)
Funder	Medical Research Council (UK)

Submission date: 02/04/2007
Registration date: 31/05/2007
Last edited: 18/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Charles Gilks
Scientific

Faculty of Medicine
Imperial College
Norfolk Place
London
W2 1PG
United Kingdom

Email	dart@ctu.mrc.ac.uk

Study information

Primary study design	Interventional
Study design	Three-centre open-label randomised pilot trial
Secondary study design	Randomised controlled trial
Scientific title	Second-line Anti-Retroviral therapy in Africa: a randomised trial to evaluate the feasibility of maintenance monotherapy with ritonavir-boosted lopinavir (Aluvia® tablets) following initiation with 24 weeks of combination therapy in second-line anti-retroviral therapy in Africa
Study acronym	SARA
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Lopinavir and ritonavir (Aluvia®/Kaletra®)
Primary outcome measure(s)	1. Change in CD4 count at 24 weeks after randomisation (efficacy) 2. Any Serious Adverse Event (SAE), which is not HIV related only (safety)
Key secondary outcome measure(s)	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
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	240
Key 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
Key exclusion criteria	Pregnant or breast-feeding
Date of first enrolment	25/07/2007
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

United Kingdom
England
Uganda
Zimbabwe

Study participating centre

Faculty of Medicine

London
W2 1PG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No

Editorial Notes

18/12/2017: publication reference added.