Clinical trial NCT02182765 (phase 1, status: terminated)
Conditions: hiv infections
ICD codes: Z21
Drugs: nevirapine, amprenavir, abacavir
SMILES: CC1=C2NC(=O)C3=C(N=CC=C3)N(C3CC3)C2=NC=C1, CC(C)CN(C[C@@H](O)[C@H](CC1=CC=CC=C1)NC(=O)O[C@H]1CCOC1)S(=O)(=O)C1=CC=C(N)C=C1, CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients between the ages of 18 and 65 years, inclusive;

          -  Plasma HIV-1 RNA >= 5000 copies/mL, documenting HIV-1 infection

          -  CD4+ cell count >= 100 cells/mm³

          -  Patients who met the following laboratory parameter:

               -  Lymphocyte count >= 1000 cells/mm³

               -  Hemoglobin >= 9.0 g/dl (men and women)

               -  Platelet count >= 75000 cells/mm3

               -  Alkaline Phosphatase <= 3.0 times the upper limit of normal

               -  Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic
                  Transaminase (SGPT) <= 3.0 times the upper limit of normal

               -  Total bilirubin <= 1.5 times the upper limit of normal

               -  Creatinine <= 2mg/dL

          -  Female patients of reproductive potential had to be willing to use a reliable method
             of double-barrier contraception (such as diaphragm with spermicidal cream or jelly, or
             condoms with spermicidal foam)

          -  Patients who were informed of and willing and able to comply with the investigational
             nature of the study and had signed a written consent in accordance with institutional
             and federal guidelines

        Exclusion Criteria:

          -  Female patients who were pregnant or breast-feeding

          -  Female patients who intended to change their double-barrier contraception method
             within 28 days prior to Study Day 0 and throughout the trial

          -  Patients who in the opinion of the investigator required treatment with a prohibited
             medication during the study including the potentially toxic substrates such as
             terfenadine, bepridil, astemizole, cisapride, triazolam, midazolam and
             ergotamine/dihydroergotamine containing regimes

          -  Patients taking known inhibitors or inducers of Cytochrome P450 metabolic enzymes
             including macrolide antibiotics (erythromycin, clarithromycin, azithromycin) azole
             antifungals (fluconazole, itraconazole) and phenytoin within 28 days prior or Study
             day 0 and throughout the trial

          -  Patients receiving immunomodulatory agents

          -  Ketoconazole, rifabutin and rifampin were excluded during screening and throughout the
             trial

          -  Patients with previous exposure to anti-retroviral, such as delavirdine, loviride,
             efavirenz, nevirapine, abacavir, saquinavir, ritonavir, indinavir, nelfinavir,
             amprenavir, zidovudine, Lamivudine (3TC), Stavudine (d4T), Didanosine (ddI) and
             Zalcitabine (ddC)

          -  Patients receiving any investigational drug or systemic corticosteroids within 30 days
             of the first dose of study medication and system corticosteroids initially as well as
             throughout the study and any antineoplastic agent of radiotherapy other than local
             skin radiotherapy treatment within 12 weeks before starting study medication

          -  Patients with malabsorption, severe chronic diarrhea or patients unable to maintain
             adequate oral intake

          -  Patients currently abusing alcohol or substance abusing; patients on methadone
             substitution programs might be considered for inclusion in the trial

          -  Patients undergoing treatment for an active infection

          -  Patients with hepatic insufficiency due to cirrhosis

          -  Patients with renal insufficiency

          -  Patients who were heavy smokers (e.g. > 20 cigarettes per day)

          -  Patients whose reliability was deemed to put them at risk for non-compliance with the
             study