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HIV InfectionPhase 4SALTNCT01307488

Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy

A Phase 4 study testing Ritonavir boosted Atazanavir + Lamivudine and Ritonavir boosted Atazanavir + 2 NRTIs in people with HIV Infection, run by Fundacion SEIMC-GESIDA at 36 sites in Spain.

Completed

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

Official record
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Trial summary

A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for… 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?
Ritonavir boosted Atazanavir + Lamivudine and Ritonavir boosted Atazanavir + 2 NRTIs
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
36 sitesSpain
Study dates
Sep 2011to Mar 2015
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

  • Signature of informed consent
  • At least 18 years old
  • Patients on their 1st ARV treatment consisting on 2 NRTIs + 1 third agent for at least 1 year
  • Undetectable viral load for at least 6 months prior to inclusion in the study (VL<50 c/mL in 2 determinations 6 months apart; blips are not allowed).
  • Requirement of ARV treatment change due to toxicity, intolerance or simplification.
  • Clinically stable.

Who cannot join

  • Pregnant women or women who plan to get pregnant during the study.
  • Breast feeding
  • History of change of any ARV treatment component for any reason 4 months prior to the inclusion in the trial
  • History of ARV treatment change due to virological failure
  • History of confirmed virological failure defined as one single VL >400 c/mL or at least 2 VL between 50 and 400 c/mL one year after an indetectable VL was achieved.
  • Absence of HIV genotype prior to ARV treatment initiation.
Show all 12Show fewer
  • Resistance mutation to any of the study drugs (ATV, RTV, 3TC)
  • HBV infection.
  • History of toxicity or intolerance to ATV, RTV or 3TC.
  • Gilbert's syndrome.
  • Use of contraindicated drugs.
  • Lab abnormalities grade 4.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

Spain36 sites

  • Hospital Juan Canalejo

    A Coruña

  • Hospital Príncipe de Asturias

    Alcalá de Henares, Madrid

  • Hospital General de Alicante

    Alicante

  • H. Universitario Central de Asturias

    Asturias, Principality of Asturias

  • H. Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital Santa Creu i Sant Pau

    Barcelona

  • Hospital Vall d'Hebrón

    Barcelona

  • Hospital de Basurto

    Basurto, Vizcaya

  • Hospital Reina Sofía

    Córdoba

  • Hospital de Elche

    Elche, Alicante

  • Hospital Arquitecto Marcide

    Ferrol, Pontevedra

  • Hospital Clínico San Cecilio

    Granada

  • Hospital Virgen de las Nieves

    Granada

  • Hospital General de Granollers

    Granollers, Barcelona

  • H. Juan Ramón Jiménez

    Huelva, Huelva

  • Hospital de Jerez

    Jerez de la Frontera, Cádiz

  • Hospital Severo Ochoa

    Leganés, Madrid

  • H. San Pedro

    Logroño, La Rioja

  • H. Clinico San Carlos

    Madrid, Madrid

  • H. Universitario Infanta Leonor

    Madrid, Madrid

  • Hospital Doce de Octubre

    Madrid

  • Hospital Gregorio Marañón

    Madrid

  • Hospital La Paz

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Virgen de la Victoria

    Málaga

  • H. Universitario Son Espases

    Mallorca, Mallorca

  • Hospital Costa del Sol

    Marbella, Málaga

  • Hospital de Mataró

    Mataró

  • Hospital de Navarra

    Pamplona

  • Hospital Donostia

    San Sebastián

  • Hospital Marqués de Valdecilla

    Santander

  • Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña

  • Hospital de Santa Tecla

    Tarragona

  • Hospital La Fe

    Valencia

  • Hospital Xeral Cíes

    Vigo, Pontevedra

  • Hospital Marina Baixa

    Villajoyosa, Alicante

Other trials in Spain

About this study

Official title: Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial

A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.

Read the detailed description

Clinical Trial, phase IV, randomized, open label, multicenter with approved drugs in their use conditions.

A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.

Conditions
HIV Infection
Being tested
Ritonavir boosted Atazanavir + Lamivudine, Ritonavir boosted Atazanavir + 2 NRTIs
Keywords
HIV, AIDS, Atazanavir, Simplification
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.

  • Ritonavir boosted Atazanavir + LamivudineDrug

    ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.

  • Ritonavir boosted Atazanavir + 2 NRTIsDrug

    ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.

Study groups in NCT01307488
Study groupRoleWhat they receive
ATV/r+3TCExperimentalSubjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.
Receives: Drug: Ritonavir boosted Atazanavir + Lamivudine
ATV/r+2 NRTIsActive comparatorSubjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.
Receives: Drug: Ritonavir boosted Atazanavir + 2 NRTIs

What is being measured

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

  1. To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs

    Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 48 weeks of treatment

    Measured: Week 48

Secondary outcomes (8)

  1. To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs

    Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 24 weeks of treatment

    Measured: week 24

  2. To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs

    Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 96 weeks of treatment

    Measured: week 96

  3. To assess safety after 24 weeks fo treatment

    Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities.

    Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.

    Measured: Week 24

  4. To assess safety after 48 weeks fo treatment

    Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities.

    Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.

    Measured: Week 48

  5. To assess safety after 96 weeks fo treatment

    Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities.

    Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.

    Measured: Week 96

  6. To assess the incidence of resistance, and characterization of this resistance following a virological rebound

    Genotypic antiretroviral resistance profiles of subjects experiencing virologic failure (genotype) Plasma samples at Baseline and at each visit will be stored for additional resistance studies (i.e. cDNA)

    Measured: Week 96

  7. To assess neurocognitive function evolution

    Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48

    Measured: Week 48

  8. To assess neurocognitive function evolution

    Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96

    Measured: Week 96

Timeline

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

  1. First posted3 Mar 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionApr 2014
  4. Study completionMar 2015

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
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307488
Sponsor's protocol ID
GESIDA 7011
Other IDs
2011-001107-12
Acronym
SALT
Status last verified
May 2015
First submitted
1 Mar 2011
Last updated
12 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suarez-Lozano I, Riera M, Estebanez M, Santos J, Sanz-Moreno J, Troya J, Marino A, Antela A, Navarro J, Esteban H, Moreno S; GESIDA 7011 Study Group. Dual treatment with atazanavir-ritonavir plus lamivudine versus triple treatment with atazanavir-ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):775-84. doi: 10.1016/S1473-3099(15)00097-3. Epub 2015 Jun 7.

    PubMed 26062881

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ritonavir boosted Atazanavir + Lamivudine and Ritonavir boosted Atazanavir + 2 NRTIs in people with HIV Infection, run by Fundacion SEIMC-GESIDA at 36 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 6 inclusion and 12 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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?

To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs (time frame: Week 48). 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 NCT01307488, which also lists 1 linked publication.

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 12 May 2015.

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