Evaluation of the benefit and the safety of a CD4-guided Highly Active Anti-Retroviral Therapy (HAART) interruption strategy in stable adult Human Immunodeficiency Virus (HIV)-infected patients
| ISRCTN | ISRCTN75856952 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75856952 |
| Secondary identifying numbers | STOPAR-03 |
- Submission date
- 04/05/2007
- Registration date
- 16/05/2007
- Last edited
- 31/07/2013
- 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
Dr Daniel Podzamczer
Scientific
Scientific
Hospital Universitari de Bellvitge
Feixa Llarga S/N
Barcelona
08907
Spain
Study information
| Study design | Randomised, open, multicentre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | STOPAR |
| Study objectives | 1. The interruption strategy will have a similar efficacy and safety than the continous Highly Active Anti-Retroviral Therapy (HAART) strategy 2. Human Immunodeficiency Virus (HIV)-chronic infected patients stable under HAART will be able to perform long-term treatment interruptions 3. The appearance of resistance mutations will be similar in both arms (HAART-interruption and HAART-continous treatment), approximately 5% of patients will present virological failure 4. Those patients following long-term HAART-interruption will improve their lipid profile and their anthropometic measures from baseline in comparison to the HAART-continous treatment patients 5. Patients achieving a long-term HAART interruption will have a better quality of life in comparison to those in HAART-continous therapy. However, patients needing to re-start and interrupt treatment frequently could have a worse quality of life than those receiving HAART-continous therapy |
| Ethics approval(s) | The trial was approved by the Spanish Drug Agency on the 26th August 2003 (ref: 03-0387). |
| Health condition(s) or problem(s) studied | Adult HIV-1 infected patients |
| Intervention | Patients will be randomised to Continue Therapy (CT) or to Therapy Interruption (TI); those treated with a NNRTI will discontinue the drug seven days before the nucleoside backbone. Standard antiretroviral drug doses will be used throughout the study period. CT arm: Clinical monitoring including adverse effect and other clinical event assessment, anthropometric measures, and blood tests (routine biochemical, haematology parameters, viral load, CD4 counts, lipid profile) will be performed at month one and every three months thereafter. TI arm: The same schedule, plus an extra visit at month two. HAART will be reinitiated if CD4 count decreases to less than 350 cells/mm^3 and re-discontinued if CD4 is greater than 500 and viral load less than 50 copies/mL for at least three months. Genotypic resistant tests will be performed in patients with virological failure (confirmed greater than 1000 copies/mL in CT arm and detectable viral load after six-month reintroduction of HAART in TI arm) Overall follow up will be three years, with interim analyses after one and two years of follow-up. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Highly Active Anti-Retroviral Therapy (HAART) |
| Primary outcome measure | Clinical (progression to AIDS, or any of the following HIV-associated clinical infections: oral candidiasis, multimetameric herpes zoster, leishmaniasis), virological (confirmed greater than 1000 copies/mL in CT arm and detectable viral load after six-month reintroduction of HAART in TI arm) or immunologic (confirmed CD4 < 200 cells/uL) failure. |
| Secondary outcome measures | 1. Time to failure (assessed by log-rank test) 2. Switch due to toxicity (clinical and laboratory evaluation in every visit) 3. Lipid (total cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides measured in every visit) and body fat changes (by patient and physician clinical observation and anthropometric measures, at baseline and at one, two and three years) 4. Quality of life (assessed by Medical Outcomes Study HIV Health Survey [MOS-HIV] questionnaire at baseline and at one, two and three years) |
| Overall study start date | 28/01/2004 |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 170 patients (85 patients by arm) |
| Key inclusion criteria | 1. Adult HIV-1 infected patients treated with HAART (two Nucleoside analogue Reverse Transcriptase Inhibitors [NRTIs] plus a Non-Nucleoside Reverse Transcriptase Inhibitor [NNRTI] or two NRTIs plus one or two Protease Inhibitors [PIs]) 2. Stable clinical status without HAART changes in the last six months 3. Undetectable viral load (less than 50 copies/mL) in the last six months 4. CD4 greater than 500 cell/mm^3 in the last three months 5. No more than a previous virological failure leading to HAART modification 6. Written informed consent |
| Key exclusion criteria | 1. Previous Acquired Immune Deficiency Syndrome (AIDS) (except oesophageal candidiasis, pulmonary tuberculosis, recurrent pneumonia and wasting syndrome) 2. CD4 nadir less than 100 cells/mm^3 3. Positive Hepatitis B surface Antigen (HBsAg) using tenofovir and/or lamivudine 4. Child C-cirrhosis 5. Current therapy with immunosuppressive or immunomodulator drugs (including interleukines and interpheron), corticosteroids or chemotherapy 6. Current and previous treatment with HIV-immunogen drugs 7. Pregnancy or breast feeding 8. Patients included in other clinical trials or experimental studies |
| Date of first enrolment | 28/01/2004 |
| Date of final enrolment | 30/05/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Universitari de Bellvitge
Barcelona
08907
Spain
08907
Spain
Sponsor information
Spanish AIDS Research Network (Red de Investigacion en SIDA [RIS]) (Spain)
Research organisation
Research organisation
Instituto de Salud Carlos III
C/Sinesio Delgado Nº 6
Madrid
28029
Spain
| Website | http://www.retic-ris.net/default_principal.asp?idx=&cidioma=2 |
|---|
Funders
Funder type
Research organisation
Spanish AIDS Research Network (Red de Investigacion en SIDA [RIS]) (Spain)
No information available
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 | 01/02/2013 | Yes | No |
