Skip to main content
OpenTrials
Completed

NCT Number: NCT01307488

Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Elche, Elche, Alicante, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Ritonavir boosted Atazanavir + Lamivudine

Drug

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 NRTIs

Drug

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.

Primary outcomes

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

    Time frame: Week 48

    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

Secondary outcomes

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

    Time frame: week 24

    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

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

    Time frame: week 96

    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

  3. To assess safety after 24 weeks fo treatment

    Time frame: Week 24

    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.

  4. To assess safety after 48 weeks fo treatment

    Time frame: Week 48

    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.

  5. To assess safety after 96 weeks fo treatment

    Time frame: Week 96

    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.

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

    Time frame: Week 96

    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)

  7. To assess neurocognitive function evolution

    Time frame: Week 48

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

  8. To assess neurocognitive function evolution

    Time frame: Week 96

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

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: SALT

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Mar 3, 2011
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.