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 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Prof Charles Gilks
Scientific
Scientific
Faculty of Medicine
Imperial College
Norfolk Place
London
W2 1PG
United Kingdom
| dart@ctu.mrc.ac.uk |
Study information
| Study design | Three-centre open-label randomised pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 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(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) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lopinavir and ritonavir (Aluvia®/Kaletra®) |
| Primary outcome measure | 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 study start date | 25/07/2007 |
| Overall study end date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 240 |
| 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 exclusion criteria | Pregnant or breast-feeding |
| Recruitment start date | 25/07/2007 |
| Recruitment end date | 30/09/2009 |
Locations
Countries of recruitment
- England
- Uganda
- United Kingdom
- Zimbabwe
Study participating centre
Faculty of Medicine
London
W2 1PG
United Kingdom
W2 1PG
United Kingdom
Sponsor information
Medical Research Council Clinical Trials Unit (UK)
Government
Government
222 Euston Road
London
NW1 2DA
United Kingdom
| dart@ctu.mrc.ac.uk | |
| Website | http://www.ctu.mrc.ac.uk/ |
"ROR" |
https://ror.org/001mm6w73 |
Funders
Funder type
Government
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
