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A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression.
Pediatr Infect Dis J. 2015 Apr; 34(4):376-82.PI

Abstract

BACKGROUND

The safety and efficacy of tenofovir disoproxil fumarate (TDF) in HIV-1-infected children have not been evaluated in a randomized controlled trial.

METHODS

Subjects (2 to <16 years) on a stavudine (d4T) or zidovudine (ZDV) containing regimen with HIV-1 RNA <400 copies/mL were randomized to either switch d4T or ZDV to TDF or continue d4T or ZDV. The primary endpoint was the proportion of subjects with HIV-1 RNA < 400 copies/mL at Week 48 with a prespecified noninferiority margin of 15%. After the 48-week randomized phase, eligible subjects were rolled over to an extension phase.

RESULTS

Ninety-seven children (48 TDF vs. 49 d4T or ZDV) were randomized and treated. The percent of subjects who maintained virologic suppression in the TDF versus d4T or ZDV group at Week 24 were 93.8% versus 89.8% (difference 4.0%; 95% confidence interval:: -6.9% to 14.9%) and at Week 48 were 83.3% versus 91.8% (difference: -8.5%; 95% confidence interval: -21.5% to 4.5%; missing = failure, intent-to-treat analysis). No subjects discontinued study drug because of an adverse event in the 48 weeks of randomized phase. Four subjects discontinued TDF because of proximal renal tubulopathy in the extension phase.

CONCLUSIONS

Our study did not demonstrate noninferiority of TDF versus d4T or ZDV at Week 48. Overall safety and tolerability of TDF in children were consistent with adults. TDF may be considered as an alternative to d4T or ZDV in HIV-infected children.

Authors+Show Affiliations

From the *Department of Infectious Diseases, Hospital del Niño, Panama City, Panama; †Division of Pediatric Infectious Disease and Immunology, University of Florida Health Science Center, Jacksonville, FL; ‡Division of Clinical Immunology and Allergy, Children's Hospital Los Angeles; §Division of Pediatric Infectious Diseases, University of California in Los Angeles, Los Angeles, CA; ¶Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN; ‖Gilead Sciences Inc., Foster City; and **Dynavax Technologies, Berkley, CA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25760565

Citation

Saez-Llorens, Xavier, et al. "A Randomized, Open-label Study of the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate in HIV-1-infected Children With Virologic Suppression." The Pediatric Infectious Disease Journal, vol. 34, no. 4, 2015, pp. 376-82.
Saez-Llorens X, Castaño E, Rathore M, et al. A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression. Pediatr Infect Dis J. 2015;34(4):376-82.
Saez-Llorens, X., Castaño, E., Rathore, M., Church, J., Deville, J., Gaur, A., Estripeaut, D., White, K., Arterburn, S., Enejosa, J. V., Cheng, A. K., Chuck, S. L., & Rhee, M. S. (2015). A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression. The Pediatric Infectious Disease Journal, 34(4), 376-82. https://doi.org/10.1097/INF.0000000000000289
Saez-Llorens X, et al. A Randomized, Open-label Study of the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate in HIV-1-infected Children With Virologic Suppression. Pediatr Infect Dis J. 2015;34(4):376-82. PubMed PMID: 25760565.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression. AU - Saez-Llorens,Xavier, AU - Castaño,Elizabeth, AU - Rathore,Mobeen, AU - Church,Joseph, AU - Deville,Jaime, AU - Gaur,Aditya, AU - Estripeaut,Dora, AU - White,Kirsten, AU - Arterburn,Sarah, AU - Enejosa,Jeffrey V, AU - Cheng,Andrew K, AU - Chuck,Steven L, AU - Rhee,Martin S, PY - 2015/3/12/entrez PY - 2015/3/12/pubmed PY - 2015/11/17/medline SP - 376 EP - 82 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 34 IS - 4 N2 - BACKGROUND: The safety and efficacy of tenofovir disoproxil fumarate (TDF) in HIV-1-infected children have not been evaluated in a randomized controlled trial. METHODS: Subjects (2 to <16 years) on a stavudine (d4T) or zidovudine (ZDV) containing regimen with HIV-1 RNA <400 copies/mL were randomized to either switch d4T or ZDV to TDF or continue d4T or ZDV. The primary endpoint was the proportion of subjects with HIV-1 RNA < 400 copies/mL at Week 48 with a prespecified noninferiority margin of 15%. After the 48-week randomized phase, eligible subjects were rolled over to an extension phase. RESULTS: Ninety-seven children (48 TDF vs. 49 d4T or ZDV) were randomized and treated. The percent of subjects who maintained virologic suppression in the TDF versus d4T or ZDV group at Week 24 were 93.8% versus 89.8% (difference 4.0%; 95% confidence interval:: -6.9% to 14.9%) and at Week 48 were 83.3% versus 91.8% (difference: -8.5%; 95% confidence interval: -21.5% to 4.5%; missing = failure, intent-to-treat analysis). No subjects discontinued study drug because of an adverse event in the 48 weeks of randomized phase. Four subjects discontinued TDF because of proximal renal tubulopathy in the extension phase. CONCLUSIONS: Our study did not demonstrate noninferiority of TDF versus d4T or ZDV at Week 48. Overall safety and tolerability of TDF in children were consistent with adults. TDF may be considered as an alternative to d4T or ZDV in HIV-infected children. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/25760565/A_randomized_open_label_study_of_the_safety_and_efficacy_of_switching_stavudine_or_zidovudine_to_tenofovir_disoproxil_fumarate_in_HIV_1_infected_children_with_virologic_suppression_ L2 - https://doi.org/10.1097/INF.0000000000000289 DB - PRIME DP - Unbound Medicine ER -