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Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy

Information source: Fundacion SEIMC-GESIDA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Intervention: Ritonavir boosted Atazanavir + Lamivudine (Drug); Ritonavir boosted Atazanavir + 2 NRTIs (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Fundacion SEIMC-GESIDA

Official(s) and/or principal investigator(s):
José A Pérez-Molina, MD, Principal Investigator, Affiliation: Hospital Universitario Ramon y Cajal

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 maintenance of virological suppression.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

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

To assess safety after 24 weeks fo treatment

To assess safety after 48 weeks fo treatment

To assess safety after 96 weeks fo treatment

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

To assess neurocognitive function evolution

To assess neurocognitive function evolution

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hospital General de Alicante, Alicante, Spain

H. Universitario Central de Asturias, Asturias, Spain

Hospital Santa Creu i Sant Pau, Barcelona, Spain

Hospital Vall d'Hebrón, Barcelona, Spain

Hospital Reina Sofía, Córdoba, Spain

Hospital Clínico San Cecilio, Granada, Spain

Hospital Virgen de las Nieves, Granada, Spain

H. Juan Ramón Jiménez, Huelva, Spain

Hospital Juan Canalejo, La Coruña, Spain

H. Clinico San Carlos, Madrid, Spain

H. Universitario Infanta Leonor, Madrid, Spain

Hospital Doce de Octubre, Madrid, Spain

Hospital Gregorio Marañón, Madrid, Spain

Hospital La Paz, Madrid, Spain

Hospital Ramón y Cajal, Madrid, Spain

H. Universitario Son Espases, Mallorca, Spain

Hospital de Mataró, Mataró, Spain

Hospital Virgen de la Victoria, Málaga, Spain

Hospital de Navarra, Pamplona, Spain

Hospital Donostia, San Sebastián, Spain

Hospital Marqués de Valdecilla, Santander, Spain

Hospital de Santa Tecla, Tarragona, Spain

Hospital La Fe, Valencia, Spain

Hospital de Elche, Elche, Alicante, Spain

Hospital Marina Baixa, Villajoyosa, Alicante, Spain

H. Germans Trias i Pujol, Badalona, Barcelona, Spain

Hospital General de Granollers, Granollers, Barcelona, Spain

Hospital de Jerez, Jerez de la Frontera, Cádiz, Spain

Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, La Coruña, Spain

H. San Pedro, Logroño, La Rioja, Spain

Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain

Hospital Severo Ochoa, Leganés, Madrid, Spain

Hospital Costa del Sol, Marbella, Málaga, Spain

Hospital Arquitecto Marcide, El Ferrol, Pontevedra, Spain

Hospital Xeral Cíes, Vigo, Pontevedra, Spain

Hospital de Basurto, Basurto, Vizcaya, Spain

Additional Information

Starting date: September 2011
Last updated: May 8, 2015

Page last updated: August 23, 2015

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