AzTrials
AzTrials

HIV InfectionPhase 4NCT00114933

"OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects

A Phase 4 study testing Stopping nucleosides and continuing lopinavir/ritonavir monotherapy in people with HIV Infection, run by Arribas, Jose R., M.D. at 28 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
Stopping nucleosides and continuing lopinavir/ritonavir monotherapy
How many people
200 participants
Where
28 sitesSpain
Study dates
Jan 2005to May 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV patients > 18 years old who provide signed and dated Informed consent.
  • HIV patients who have been receiving lopinavir/ritonavir and two nucleosides during at least 4 weeks.
  • Plasma HIV RNA < 50 cop/ml for six months

Who cannot join

  • HIV patients who have stopped a protease inhibitor due to virological failure.
  • HIV patients with hepatic or renal insufficiency.
  • HIV patients with positive serum HBVAg
  • HIV patients who require treatment with a lopinavir/r contraindicated medication.
  • HIV pregnant or breastfeeding women.
  • Active drug abuse (including alcohol or recreational drugs). Exception, cannabis, provided the investigator is confident in patient adherence. Patients under Methadone program will be accepted too if deemed appropriate by the investigator.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Spain28 sites

  • Hospital U. Príncipe de Asturias

    Alcalá de Henares, Madrid, 28880

  • Hospital General de Alicante

    Alicante, Alicante, 03010

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital Sant Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Clinic i Provincial

    Barcelona, Barcelona, 08036

  • Hospital Germans Trias i Pujol

    Barcelona, Barcelona, 08916

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital General de Elche

    Elche, Alicante, 03202

  • Hospital Virgen de las Nieves

    Granada, Granada, 18014

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Insular

    Las Palmas de Gran Canaria, Gran Canaria, 35500

  • Hospital La Paz

    Madrid, Madrid, 28 046

  • Hospital La Princesa

    Madrid, Madrid, 28006

  • Hospital Gregorio Marañón

    Madrid, Madrid, 28007

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034

  • Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital de Donostia

    San Sebastián, Guipuzcoa, 20014

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Tenerife, 38010

  • Hospital Virgen Macarena

    Seville, Sevilla, 41009

  • Hospital Nuestra Señora de Valme (Sevilla)

    Seville, Sevilla, 41014

  • Hospital La Fe

    Valencia, Valencia, 46009

  • Hospital Clínico de Valencia

    Valencia, Valencia, 46010

  • Hospital General de Valencia

    Valencia, Valencia, 46014

  • Hospital Dr. Peset

    Valencia, Valencia, 46017

  • Hospital Xeral Cies

    Vigo, Pontevedra, 362004

  • Hospital Miguel Servet

    Zaragoza, Zaragoza, 50010

Other trials in Spain

About this study

Official title: Phase III-IV, Comparative, Randomized, Open-Label, Study to Evaluate Safety and Efficacy of Suspending Nucleosides From a Triple-Drug Therapy Based on Lopinavir/Ritonavir Versus Continuing Triple-Drug Therapy in HIV-Infected Subjects With Undetectable Plasma HIV Viremia for Six Months

Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification.

Read the detailed description

Primary Study Objective: Efficacy and durability of switching to lopinavir/ritonavir single-drug HAART compared to maintaining therapy based on lopinavir/ritonavir and two nucleosides

Secondary Study Objective(s):

  • Safety (related drug AEs/SAEs and laboratory anomalies G3/4) through 48 w.
  • Resistance profile on patients with sustained virological failure
  • QOL comparing stopping nucleosides versus continuing therapy
  • Pharmaco-economic analysis comparing treatment cost between the 2 study arms.
  • Predicting factors of failure in the stopping nucleosides arm

Subject Population: 200 patients

Study Design:

RANDOMIZATION:

Patients are randomized (1:1) either to continue under the same treatment or stop nucleosides as follows:

  • Stopping nucleosides arm: Lopinavir/r alone.
  • Continuing arm: Lopinavir/r + 2 NRTIs

STUDY PROCEDURES: A baseline HIV-RNA, CD4 and routine labs will be collected if the most recent results are not collected within the 4 weeks prior entering the study. Patients will be followed for HIV-RNA (and CD4) at w1, w4, w8, w16, w24, w 36 and w48. After w48, durability of response to lopinavir/r single-drug therapy will be studied long-term (up to w96). Routine hematology and clinical chemistry (including fasting triglycerides and cholesterol, total and HDL/LDL ratio) will be measured at w4, w16, w24, w 36 and w48. A central laboratory will be used for HIV-RNA determinations and to archive plasma/cell samples for further genotype test in case of rebound.

Treatment adherence will be followed with a self-patient report questionnaire (GEEMA study)

All AEs will be collected if suspected relation (possible or probable) to any concomitant ARV drug, and SAEs, related or not, reported within 24h.

Conditions
HIV Infection
Being tested
Stopping nucleosides and continuing lopinavir/ritonavir monotherapy
Keywords
HIV, AIDS, Treatment Experienced
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stopping nucleosides and continuing lopinavir/ritonavir monotherapyDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % patients with therapeutic failure in both arms at 48 weeks (OT and ITT)

Secondary outcomes (6)

  1. % patients with virological failure: HIV-RNA > 500 cop/ml under the randomly assigned therapy (OT and ITT)

  2. % patients with HIV RNA < 500 cop/ml and < 50 cop/ml at w24, w48 (OT and ITT)

  3. Time to virological failure per Kaplan Meyer analysis

  4. CD4 cell count change from baseline

  5. Percentage of viruses with resistance in the protease gene at w24 and w48

  6. Description of AEs with probable, possible or unknown relationship to study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2005 (estimated)
  2. Study startJan 2005
  3. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00114933
Sponsor's protocol ID
SPA-378-05-40
Other IDs
EudraCT 2004-001323-37
Status last verified
Sep 2005
First submitted
20 Jun 2005
Last updated
21 Mar 2008
Results posted
No

Publications

  • Arribas JR, Delgado R, Arranz A, Munoz R, Portilla J, Pasquau J, Perez-Elias MJ, Iribarren JA, Rubio R, Ocampo A, Sanchez-Conde M, Knobel H, Arazo P, Sanz J, Lopez-Aldeguer J, Montes ML, Pulido F; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):147-52. doi: 10.1097/QAI.0b013e3181a56de5.

    PubMed 19349870

  • Pulido F, Arribas JR, Delgado R, Cabrero E, Gonzalez-Garcia J, Perez-Elias MJ, Arranz A, Portilla J, Pasquau J, Iribarren JA, Rubio R, Norton M; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS. 2008 Jan 11;22(2):F1-9. doi: 10.1097/QAD.0b013e3282f4243b.

    PubMed 18097218

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stopping nucleosides and continuing lopinavir/ritonavir monotherapy in people with HIV Infection, run by Arribas, Jose R., M.D. at 28 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% patients with therapeutic failure in both arms at 48 weeks (OT and ITT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00114933, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in