This phase I trial for safety and efficacy of a novel drug against human immunodeficiency virus (HIV) requires adequate representation across the pediatric age spectrum. Escalation in dosage requires completion of all age strata. Very few HIV-infected children have been identified under age 2 years, reflecting the success of AZT prophylaxis against maternal to infant transmission. Escalation of ACTG 310 was stymied because of lack of enrollment of younger children. An intensive effort at our institution resulted in enrollment of the entire national age < 2 yrs cohort, establishing safety and bioavailability, and promoting subsequent escalation in dosage of the trial. We anticipate providing additional representation in this crucial age range at the higher drug dosage. Successful completion of this trial will lead to an efficacy trial of adefovir dipivoxil in children. Adefovir is the first drug against HIV targeted for early trials in children concurrent with trials in adults. Early trials in children are necessary to address the severe shortage of anti-HIV drugs in children relative to adults (3 vs. 10 drugs available in 1996). Adefovir is currently in early trials in adults as part of new generation """"""""cocktails"""""""" in combination with protease inhibitors. Pediatric trials should follow shortly. Adefovir is likely to improve pediatric HIV care, providing more options for """"""""pediatric cocktails"""""""" against HIV. The drug has promising activity against cytomegalovirus, an HIV co-pathogen in children, making it doubly attractive.
| Aboud, Katherine S; Barquero, Laura A; Cutting, Laurie E (2018) Prefrontal mediation of the reading network predicts intervention response in dyslexia. Cortex 101:96-106 |
| Kattan, Meyer; Bacharier, Leonard B; O'Connor, George T et al. (2018) Spirometry and Impulse Oscillometry in Preschool Children: Acceptability and Relationship to Maternal Smoking in Pregnancy. J Allergy Clin Immunol Pract 6:1596-1603.e6 |
| Altekruse, Sean F; Shiels, Meredith S; Modur, Sharada P et al. (2018) Cancer burden attributable to cigarette smoking among HIV-infected people in North America. AIDS 32:513-521 |
| Salemi, Parissa; Skalamera Olson, Julie M; Dickson, Lauren E et al. (2018) Ossifications in Albright Hereditary Osteodystrophy: Role of Genotype, Inheritance, Sex, Age, Hormonal Status, and BMI. J Clin Endocrinol Metab 103:158-168 |
| Robert BraĊĦi?, James; Mari, Zoltan; Lerner, Alicja et al. (2018) Remission of Gilles de la Tourette Syndrome after Heat-Induced Dehydration. Int J Phys Med Rehabil 6: |
| Altman, Matthew C; Whalen, Elizabeth; Togias, Alkis et al. (2018) Allergen-induced activation of natural killer cells represents an early-life immune response in the development of allergic asthma. J Allergy Clin Immunol 142:1856-1866 |
| AIDS-defining Cancer Project Working Group of IeDEA, COHERE in EuroCoord (2018) Non-Hodgkin lymphoma risk in adults living with HIV across five continents. AIDS 32:2777-2786 |
| Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671 |
| Elion, Richard A; Althoff, Keri N; Zhang, Jinbing et al. (2018) Recent Abacavir Use Increases Risk of Type 1 and Type 2 Myocardial Infarctions Among Adults With HIV. J Acquir Immune Defic Syndr 78:62-72 |
| Al-Sofiani, Mohammed E; Yanek, Lisa R; Faraday, Nauder et al. (2018) Diabetes and Platelet Response to Low-Dose Aspirin. J Clin Endocrinol Metab 103:4599-4608 |
Showing the most recent 10 out of 1014 publications
