Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Daniel Podzamczer


Contact details

Hospital Universitari de Bellvitge
Feixa Llarga S/N

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Adult HIV-1 infected patients


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group



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


Recruitment end date



Countries of recruitment


Trial participating centre

Hospital Universitari de Bellvitge

Sponsor information


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

Sponsor details

Instituto de Salud Carlos III
C/Sinesio Delgado Nº 6

Sponsor type

Research organisation



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


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

Basic results (scientific)

Publication list

2013 results in

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