A Randomized Study of Tenofovir Disoproxil Fumarate in Treatment-experienced HIV-1 Infected Adolescents
The Pediatric Infectious Disease Journal,

Negra MD et al. – This study of tenofovir disoproxil fumarate (TDF) in combination with an optimized background regimen (OBR) in antiretroviral–experienced adolescents did not meet its primary or secondary efficacy endpoints. The effectiveness of the OBR and baseline genotypic resistance to TDF in both groups may have confounded the efficacy findings. No clinically relevant TDF–related renal or bone toxicities were observed in this adolescent population.

Methods
  • A randomized, double-blinded, placebo-controlled study was conducted.
  • Ninety adolescents (12 to <18 years) who were viremic while receiving antiretroviral treatment were randomized to receive TDF 300 mg (mean, 216.8 mg/m2) or placebo in combination with an optimized background regimen (OBR) for 48 weeks.
  • The primary efficacy endpoint was time-weighted average change in plasma HIV-1 RNA from baseline at week 24.

Results
  • Eighty-seven subjects (45 TDF, 42 placebo) received the study drug.
  • Through week 24, the median time-weighted average change in plasma HIV-1 RNA was not different between the TDF and placebo groups.
  • The percentages of subjects who achieved HIV-1 RNA <400 copies/mL were similar at week 24 (40.9 versus 41.5%).
  • One fourth of subjects in the TDF and placebo groups (24.4 versus 28.6%) had at least 3 active agents in the OBR.
  • Many subjects in both groups had baseline genotypic resistance to TDF (48.9 versus 33.3%).
  • TDF was generally safe and well tolerated. There were no statistically significant differences in changes of renal function and bone mineral density between the 2 groups.

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Physician Assistant

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Physician Assistant Articles

1 Dance for Parkinson's: A new framework for research on its physical, mental, emotional, and social benefits Complementary Therapies in Medicine, June 17, 2014    Review Article

2 Statins in the elderly: an answered question Current Opinion in Cardiology, June 9, 2014    Evidence Based Medicine    Review Article    Clinical Article

3 Efficacy of high-dose versus standard-dose influenza vaccine in older adults New England Journal of Medicine, August 15, 2014    Evidence Based Medicine    Clinical Article

4 Hepatitis a hospitalizations in the United States, 2002 – 2011 Hepatology, October 3, 2014    Clinical Article

5 A statin a day to keep the doctor away? comparing aspirin and statins for primary prevention of cardiovascular disease Annals of Pharmacotherapy, August 7, 2014    Clinical Article

6 Vitamin D and mortality: meta-analysis of individual participant data from a large consortium of cohort studies from Europe and the United States BMJ, June 24, 2014    Evidence Based Medicine    Clinical Article

7 Consumption of nuts and legumes and risk of stroke: a meta-analysis of prospective cohort studies Nutrition, Metabolism & Cardiovascular Diseases, July 25, 2014    Evidence Based Medicine    Clinical Article

8 Hemoglobin A1c levels and risk of severe hypoglycemia in children and young adults with type 1 diabetes from Germany and Austria: a trend analysis in a cohort of 37,539 patients between 1995 and 2012 Full Text PLoS Medicine, October 10, 2014    Free full text    Evidence Based Medicine    Clinical Article

9 Effects of decontamination of the oropharynx and intestinal tract on antibiotic resistance in ICUs: a randomized clinical trial JAMA, October 10, 2014    Evidence Based Medicine    Clinical Article

10 The effectiveness of metoprolol versus atenolol on prevention of all-cause and cardiovascular mortality in a large Chinese population: A cohort study International Journal of Cardiology, June 27, 2014    Clinical Article

11 Vitamin E and C supplementation and risk of cancer in men: posttrial follow-up in the Physicians’ Health Study II randomized trial American Journal of Clinical Nutrition, July 10, 2014    Clinical Article

12 The effect of indapamide versus hydrochlorothiazide on ventricular and arterial function in patients with hypertension and diabetes: Results of a randomized trial American Heart Journal, October 3, 2014    Clinical Article

13 Meta-analysis of non-steroidal anti-inflammatory drug use and risk of atrial fibrillation The American Journal of Cardiology, October 3, 2014    Evidence Based Medicine    Review Article    Clinical Article

14 Switching from allopurinol to febuxostat for the treatment of hyperuricemia and renal function in patients with chronic kidney disease Clinical Rheumatology, October 10, 2014    Clinical Article

15 Calcium channel blocker compared with angiotensin receptor blocker for patients with hypertension: a meta-analysis of randomized controlled trials The Journal of Clinical Hypertension, August 13, 2014    Evidence Based Medicine    Review Article    Clinical Article

16 Cardiac dysfunction associated with a nucleotide polymerase inhibitor for treatment of hepatitis C Hepatology, October 3, 2014    Clinical Article

17 Randomized trial of vitamin D supplementation for winter-related atopic dermatitis in children The Journal of Allergy and Clinical Immunology, October 10, 2014    Clinical Article

18 The management of cirrhosis in women Alimentary Pharmacology and Therapeutics, October 10, 2014    Review Article

19 Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12 Journal of Clinical Oncology, October 17, 2014    Clinical Article

20 Management of high-grade gliomas in the elderly Seminars in Radiation Oncology, October 3, 2014    Clinical Article

Indexed Journals in Physician Assistant: Advance for Physicians Assistants, American Family Physicianmore