Phase
Condition
Hiv Infections
Hiv/aids
Aids And Aids Related Infections
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria: Inclusion Criteria:
Signed informed consent in accordance with Good Clinical Practice (GCP) and localregulatory requirements prior to trial participation
HIV-1-infected males or females >= 18 years of age with positive serology confirmed byWestern blot
No previous antiretroviral treatment (of more than 7 days)
Males with CD4+ counts of < 400 cells/mm3 and females with CD4+ counts of < 250cells/mm3
NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report
Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50ml/min according to the Cockcroft-Gault formula
Karnofsky score >= 70
Acceptable medical history, as assessed by the investigator
Exclusion
Exclusion criteria: Exclusion Criteria:
Active drug abuse or chronic alcoholism at the investigator's discretion
Hepatic cirrhosis stage Child-Pugh B or C
Female patients of child-bearing potential who:
have a positive serum pregnancy test at screening or during the study,
are breast feeding,
are planning to become pregnant,
are not willing to use a barrier method of contraception, or are not willing touse methods of contraception other than ethinyl estradiol containing oralcontraceptives
Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) > grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions)
Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-RiboNucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) > 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1)
Hypersensitivity to any ingredients of the test products
Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B,vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) orpotential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir,ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatorydrugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected toreceive these during the study
Patients who are receiving other concomitant treatments which are not permitted
Use of other investigational medications within 30 days before study entry or duringthe trial
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment withprednisone)
Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi'sSarcoma (KS), and/or any lymphoma
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatmentfor at least 12 weeks at screening visit
Patients who are receiving systemic treatment for malignant disease
Study Design
Connect with a study center
1100.1470.54004 Boehringer Ingelheim Investigational Site
Capital Federal,
ArgentinaSite Not Available
1100.1470.54002 Boehringer Ingelheim Investigational Site
Córdoba,
ArgentinaSite Not Available
1100.1470.54002 Boehringer Ingelheim Investigational Site
Córdoba,
ArgentinaSite Not Available
1100.1470.54003 Boehringer Ingelheim Investigational Site
Mar del Plata,
ArgentinaSite Not Available
1100.1470.54001 Boehringer Ingelheim Investigational Site
Rosario,
ArgentinaSite Not Available
1100.1470.49001 Boehringer Ingelheim Investigational Site
Berlin,
GermanySite Not Available
1100.1470.49002 Boehringer Ingelheim Investigational Site
Berlin,
GermanySite Not Available
1100.1470.49003 Boehringer Ingelheim Investigational Site
Bochum,
GermanySite Not Available
1100.1470.49018 Boehringer Ingelheim Investigational Site
Bonn,
GermanySite Not Available
1100.1470.49014 Boehringer Ingelheim Investigational Site
Düsseldorf,
GermanySite Not Available
1100.1470.49014 Boehringer Ingelheim Investigational Site
Düsseldorf,
GermanySite Not Available
1100.1470.49008 Boehringer Ingelheim Investigational Site
Erlangen,
GermanySite Not Available
1100.1470.49035 Boehringer Ingelheim Investigational Site
Frankfurt,
GermanySite Not Available
1100.1470.49036 Boehringer Ingelheim Investigational Site
Frankfurt am Main,
GermanySite Not Available
1100.1470.49033 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau,
GermanySite Not Available
1100.1470.49016 Boehringer Ingelheim Investigational Site
Hamburg,
GermanySite Not Available
1100.1470.49031 Boehringer Ingelheim Investigational Site
Hamburg,
GermanySite Not Available
1100.1470.49037 Boehringer Ingelheim Investigational Site
Hamburg,
GermanySite Not Available
1100.1470.49020 Boehringer Ingelheim Investigational Site
Hannover,
GermanySite Not Available
1100.1470.49038 Boehringer Ingelheim Investigational Site
Magdeburg,
GermanySite Not Available
1100.1470.49034 Boehringer Ingelheim Investigational Site
München,
GermanySite Not Available
1100.1470.49034 Boehringer Ingelheim Investigational Site
München,
GermanySite Not Available
1100.1470.49000 Boehringer Ingelheim Investigational Site
Ulm,
GermanySite Not Available
1100.1470.49032 Boehringer Ingelheim Investigational Site
Würzburg,
GermanySite Not Available
1100.1470.49032 Boehringer Ingelheim Investigational Site
Würzburg,
GermanySite Not Available
1100.1470.39001 Boehringer Ingelheim Investigational Site
Bergamo,
ItalySite Not Available
1100.1470.39003 Boehringer Ingelheim Investigational Site
Bologna,
ItalySite Not Available
1100.1470.39012 Ospedale Sant'Anna
Como,
ItalySite Not Available
1100.1470.39006 Boehringer Ingelheim Investigational Site
Ferrara,
ItalySite Not Available
1100.1470.39010 Boehringer Ingelheim Investigational Site
Lecco,
ItalySite Not Available
1100.1470.39004 Boehringer Ingelheim Investigational Site
Torino,
ItalySite Not Available
1100.1470.39009 Boehringer Ingelheim Investigational Site
Torrette Di Ancona,
ItalySite Not Available
1100.1470.39007 Boehringer Ingelheim Investigational Site
Varese,
ItalySite Not Available
1100.1470.55006 Boehringer Ingelheim Investigational Site
Aguascalientes,
MexicoSite Not Available
1100.1470.55004 Boehringer Ingelheim Investigational Site
Col Obregón,
MexicoSite Not Available
1100.1470.55004 Boehringer Ingelheim Investigational Site
Col Obregón,
MexicoSite Not Available
1100.1470.55008 Boehringer Ingelheim Investigational Site
Col. Los Filtros, San Luis PotosÃ,
MexicoSite Not Available
1100.1470.55008 Boehringer Ingelheim Investigational Site
Col. Los Filtros, San Luis Potosí,
MexicoSite Not Available
1100.1470.55001 Boehringer Ingelheim Investigational Site
Col. Toriello Guerra,
MexicoSite Not Available
1100.1470.55007 Boehringer Ingelheim Investigational Site
Guadalajara Jal.,
MexicoSite Not Available
1100.1470.55003 Boehringer Ingelheim Investigational Site
Tlalpan-México D,F,
MexicoSite Not Available
1100.1470.55003 Boehringer Ingelheim Investigational Site
Tlalpan-México D,F,
MexicoSite Not Available
1100.1470.48003 Boehringer Ingelheim Investigational Site
Bydgoszcz,
PolandSite Not Available
1100.1470.48001 Boehringer Ingelheim Investigational Site
Chorzow,
PolandSite Not Available
1100.1470.48002 Boehringer Ingelheim Investigational Site
Szczecin,
PolandSite Not Available
1100.1470.48004 Boehringer Ingelheim Investigational Site
Warsaw,
PolandSite Not Available
1100.1470.35102 Boehringer Ingelheim Investigational Site
Cascais,
PortugalSite Not Available
1100.1470.35101 Boehringer Ingelheim Investigational Site
Lisboa,
PortugalSite Not Available
1100.1470.35103 Boehringer Ingelheim Investigational Site
Porto,
PortugalSite Not Available
1100.1470.40001 Boehringer Ingelheim Investigational Site
Bucharest,
RomaniaSite Not Available
1100.1470.40002 Boehringer Ingelheim Investigational Site
Bucharest,
RomaniaSite Not Available
1100.1470.34013 Boehringer Ingelheim Investigational Site
Alcalá de Henares (Madrid),
SpainSite Not Available
1100.1470.34013 Boehringer Ingelheim Investigational Site
Alcalá de Henares (Madrid),
SpainSite Not Available
1100.1470.34008 Boehringer Ingelheim Investigational Site
Badalona,
SpainSite Not Available
1100.1470.34002 Boehringer Ingelheim Investigational Site
Barcelona,
SpainSite Not Available
1100.1470.34003 Boehringer Ingelheim Investigational Site
Barcelona,
SpainSite Not Available
1100.1470.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat,
SpainSite Not Available
1100.1470.34010 Boehringer Ingelheim Investigational Site
Madrid,
SpainSite Not Available
1100.1470.34012 Boehringer Ingelheim Investigational Site
Madrid,
SpainSite Not Available
1100.1470.34014 Boehringer Ingelheim Investigational Site
Madrid,
SpainSite Not Available
1100.1470.34015 Boehringer Ingelheim Investigational Site
Madrid,
SpainSite Not Available
1100.1470.34019 Boehringer Ingelheim Investigational Site
Malaga,
SpainSite Not Available
1100.1470.34007 Boehringer Ingelheim Investigational Site
Sabadell (Barcelona),
SpainSite Not Available
1100.1470.34004 Boehringer Ingelheim Investigational Site
San Sebastian,
SpainSite Not Available
1100.1470.34006 Boehringer Ingelheim Investigational Site
Santa Cruz de Tenerife,
SpainSite Not Available
1100.1470.34011 Boehringer Ingelheim Investigational Site
Vigo,
SpainSite Not Available
1100.1470.41004 Boehringer Ingelheim Investigational Site
Bern,
SwitzerlandSite Not Available
1100.1470.41001 Boehringer Ingelheim Investigational Site
Lugano,
SwitzerlandSite Not Available
1100.1470.41003 Boehringer Ingelheim Investigational Site
St. Gallen,
SwitzerlandSite Not Available
1100.1470.41002 Boehringer Ingelheim Investigational Site
Zürich,
SwitzerlandSite Not Available
1100.1470.41002 Boehringer Ingelheim Investigational Site
Zürich,
SwitzerlandSite Not Available
1100.1470.44004 Boehringer Ingelheim Investigational Site
Birmingham,
United KingdomSite Not Available
1100.1470.44001 Boehringer Ingelheim Investigational Site
London,
United KingdomSite Not Available
1100.1470.44002 Boehringer Ingelheim Investigational Site
London,
United KingdomSite Not Available
1100.1470.44005 Boehringer Ingelheim Investigational Site
London,
United KingdomSite Not Available
1100.1470.44006 Boehringer Ingelheim Investigational Site
London,
United KingdomSite Not Available
1100.1470.44003 Boehringer Ingelheim Investigational Site
Manchester,
United KingdomSite Not Available
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