Condition category
Infections and Infestations
Date applied
04/05/2007
Date assigned
16/05/2007
Last edited
31/07/2013
Prospective/Retrospective
Retrospectively 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

Dr Daniel Podzamczer

ORCID ID

Contact details

Hospital Universitari de Bellvitge
Feixa Llarga S/N
Barcelona
08907
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STOPAR-03

Study information

Scientific title

Acronym

STOPAR

Study hypothesis

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

The trial was approved by the Spanish Drug Agency on the 26th August 2003 (ref: 03-0387).

Study design

Randomised, open, multicentre clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Highly Active Anti-Retroviral Therapy (HAART)

Primary outcome measures

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 trial start date

28/01/2004

Overall trial end date

30/05/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

170 patients (85 patients by arm)

Participant 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

Recruitment start date

28/01/2004

Recruitment end date

30/05/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitari de Bellvitge
Barcelona
08907
Spain

Sponsor information

Organisation

Spanish AIDS Research Network (Red de Investigacion en SIDA [RIS]) (Spain)

Sponsor details

Instituto de Salud Carlos III
C/Sinesio Delgado Nº 6
Madrid
28029
Spain

Sponsor type

Research organisation

Website

http://www.retic-ris.net/default_principal.asp?idx=&cidioma=2

Funders

Funder type

Research organisation

Funder name

Spanish AIDS Research Network (Red de Investigacion en SIDA [RIS]) (Spain)

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22805174

Publication citations

  1. Results

    Imaz A, Olmo M, Peñaranda M, Gutiérrez F, Romeu J, Larrousse M, Domingo P, Oteo JA, Curto J, Vilallonga C, Masiá M, López-Aldeguer J, Iribarren JA, Podzamczer D, , Short-term and long-term clinical and immunological consequences of stopping antiretroviral therapy in HIV-infected patients with preserved immune function., Antivir. Ther. (Lond.), 2013, 18, 1, 125-130, doi: 10.3851/IMP2249.

Additional files

Editorial Notes