Once a Day (QD) - Twice a Day (BID) Clinical Trial: Didanosine, Lamivudine and Efavirenz Versus Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of HIV
A Multicenter, Randomized, Open Label, Clinical Trial Comparing a QD Regimen of Didanosine, Lamivudine and Efavirenz With a Standard BID Regimen of Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of Human Immunodeficiency Virus Infection (GESIDA 39/03)
1 other identifier
interventional
360
1 country
57
Brief Summary
The purpose of this study is to compare the antiviral activity of two treatment groups for HIV chronic infection: a QD regimen of didanosine, lamivudine and efavirenz versus a BID regimen of zidovudine, lamivudine and efavirenz. Both will be administered with food in the starting treatment of human immunodeficiency virus infection at Week 48.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
Started Jun 2004
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 21, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedOctober 16, 2007
November 1, 2005
November 21, 2005
October 15, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with HIV-RNA levels < 50 c/ml (intent-to-treat [ITT])
Secondary Outcomes (6)
Percentage of patients with HIV-RNA level < 400 c/ml
Time to therapy failure
CD4 cell count increase from Baseline to Week 48 (w48)
Quality of life changes
Compliance to both treatment regimens
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Chronic HIV infection with plasma RNA viral burden of HIV \> 2,000 copies/ml obtained in the month prior to randomization.
- Ages 18 years or older.
- Women with childbearing potential should use an effective contraceptive method.
- The subjects should give their written informed consent.
- The subjects should provide the baseline laboratory values measured during the 4 weeks prior to the start of the study drugs, specified below:
- serum creatinine \< 1.5 times the upper normal limit;
- total amylase \< 1.4 times the upper normal limit;
- liver enzymes (AST, ALT) \< 4 times the upper normal limit.
You may not qualify if:
- Previous antiretroviral treatment.
- Suspected (acute) primary HIV infection starting less than six months before.
- Patients under methadone program
- Abuse of alcohol or drugs, sufficient, in the investigator's opinion, to prevent an adequate compliance with the study treatment or that could increase the risk of developing pancreatitis or toxic hepatitis.
- Pregnancy or nursing.
- History of bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy \> Grade 2 on screening.
- Inability to tolerate oral drugs.
- Any other clinical condition or previous therapy that, in the investigator's opinion, leads the patient to be inadequate for the study or unable to comply with the dosage requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Hospital Universitario de San Juan de Alicante
Alicante, Alicante, 03550, Spain
Hospital General de Área de Elda
Elda, Alicante, 03600, Spain
Hospital de Orihuela-Vega Baja, San Bartolomé-Orihuela
Orihuela, Alicante, 03314, Spain
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital Santa Creu y Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital General Vall D'Hebrón
Barcelona, Barcelona, 08035, Spain
Hospital de Mollet
Barcelona, Barcelona, 08100, Spain
Consorcio Sanitario de Mataró
Barcelona, Barcelona, 08304, Spain
Hospital De Vic
Barcelona, Barcelona, 08500, Spain
Hospital General de Granollers
Granollers, Barcelona, 08400, Spain
Hospital de Terrassa
Terrassa, Barcelona, 08227, Spain
Hospital Sant Llorenc de Viladecans
Viladecans, Barcelona, 08840, Spain
Hospital General Yagüe
Burgos, Burgos, 09005, Spain
Hospital General de Jerez de la Frontera11407
Jerez de la Frontera, Cadiz, 11407, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Sierrallana de Torrelavega
Torrelavega, Cantabria, 39300, Spain
Hospital General de Castellón
Castellon, Castellon, 12004, Spain
Hospital Provincial Reina Sofía de Córdoba
Córdoba, Cordoba, 14004, Spain
Hospital Provincial Nuestra Señora de la Montaña-Complejo Hospitalario de Cáceres
Cáceres, Cáceres, 10003, Spain
Hospital Comarcal de la Selva
Blanes, Gerona, 17300, Spain
Hospital de Figueres
Figueras, Gerona, 17600, Spain
Hospital de Palamós
Palamós, Gerona, 17230, Spain
Hospital Clínico Universitario San Cecilio
Granada, Granada, 18012, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014, Spain
Hospital Donostia
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Hospital General San Jorge
Huesca, Huesca, 22004, Spain
Hospital Ciudad de Jaén
Jaén, Jaen, 23007, Spain
Hospital Juan Canalejo
A Coruña, La Coruña, 15006, Spain
Hospital Arquitecto Marcide
Ferrol, La Coruña, 15405, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, 28880, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital de la Princesa
Madrid, Madrid, 28006, Spain
Hospital Gregorio Marañón
Madrid, Madrid, 28007, Spain
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
Hospital La Paz
Madrid, Madrid, 28046, Spain
Hospital Carlos Haya
Málaga, Malaga, 29010, Spain
Hospital Virgen de la Victoria
Málaga, Malaga, 29010, Spain
Hospital Comarcal Axarquía de Vélez
Málaga, Malaga, 29740, Spain
Hospital General Universitario de Murcia
Murcia, Murcia, 30003, Spain
Hospital General Universitario Morales Meseguer
Murcia, Murcia, 30008, Spain
Hospital Costa del Sol
Marbella, Málaga, 29600, Spain
Hospital de Covadonga-Central de Asturias
Oviedo, Oviedo, 33006, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, Pontevedra, 36001, Spain
Hospital Meixoeiro
Vigo, Pontevedra, 36200, Spain
Hospital Xeral-Cíes de Vigo
Vigo, Pontevedra, 36204, Spain
Hospital General-Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital General de Segovia
Segovia, Segovia, 40002, Spain
Hospital General Universitario Sant Joan de Reus
Reus, Tarragona, 43201, Spain
Hospital La Fe de Valencia
Valencia, Valencia, 46009, Spain
Hospital Doctor Peset
Valencia, Valencia, 46017, Spain
Hospital del Río Hortega
Valladolid, Valladolid, 47010, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Virgen de la Concha
Zamora, Zamora, 49021, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
Related Publications (1)
Berenguer J, Gonzalez J, Ribera E, Domingo P, Santos J, Miralles P, Angels Ribas M, Asensi V, Gimeno JL, Perez-Molina JA, Terron JA, Santamaria JM, Pedrol E; GESIDA 3903 Team. Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903. Clin Infect Dis. 2008 Oct 15;47(8):1083-92. doi: 10.1086/592114.
PMID: 18781872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Juan Berenguer Berenguer, MD
Gregorio Marañón Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 21, 2005
First Posted
November 22, 2005
Study Start
June 1, 2004
Study Completion
November 1, 2006
Last Updated
October 16, 2007
Record last verified: 2005-11