Eligibility NCT00561925 HIV Infections Inclusion Criteria Exclusion Criteria Active drug abuse or chronic alcoholism at the investigator's discretion Yes
No
Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive Yes
No
Female patients of child-bearing potential who: are pregnant at screening, are breast feeding, are planning to become pregnant are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives. Note: During participation in this study, females and males have to use barrier methods of contraception in addition or instead of ethinyl estradiol containing oral contraceptives. Yes
No
Laboratory parameters >DAIDS Grade 2 Yes
No
ALT/AST > DAIDS Grade 1 Yes
No
Hypersensitivity to any ingredients of the test products Yes
No
Previous use of Viramune (nevirapine) or any other antiretroviral agents (does not include use of single dose NVP for the prevention of mother to child transmission) Yes
No
Resistance to NNRTIs or either one of the components of Truvada (emtricitabine or tenofovir disoproxil fumarate) or lamivudine (3TC) based on HIV-1 genotypic resistance testing report obtained at screening Yes
No
Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information Yes
No
Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial Yes
No
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2) Yes
No
Patients who have been diagnosed with malignant disease Yes
No
Patients who in the opinion of the investigator are not candidates for inclusion in the study Yes
No
Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma Yes
No
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit Yes
No