PMID- 19541575
OWN - NLM
STAT- MEDLINE
DCOM- 20090707
LR  - 20211020
IS  - 0949-2321 (Print)
IS  - 2047-783X (Electronic)
IS  - 0949-2321 (Linking)
VI  - 14
IP  - 5
DP  - 2009 May 14
TI  - Switch from a ZDV/3TC-based regimen to a completely once daily (QD) regimen of 
      emtricitabine/tenofovir DF fixed dose combination plus a third QD agent (SONETT).
PG  - 195-9
AB  - OBJECTIVES: To assess the efficacy and safety of a treatment switch from a 
      twice-daily (BID) regimen containing zidovudine (ZDV) and lamivudine (3TC) plus a 
      third agent to a once daily (QD) regimen containing the fixed-dose combination of 
      tenofovir DF/emtri?citabine (TDF/FTC, Truvada) plus a divergent third QD agent in 
      HIV-1 infected patients. METHODS: Prospective, 48-week, non-randomised, 
      single-group, open-label, study. Fifty-one patients on stable ZDV/3TC-containing 
      HAART, with HIV-1 RNA <50 copies/ml and CD4+ T-cell count >50 cells/microl, were 
      switched to TDF/FTC plus a third agent. Plasma HIV-1 RNA, CD4+ and CD8+ T-cell 
      counts were assessed at baseline and weeks 4, 12, 24, 36 and 48 post-switch. 
      RESULTS: During the 48-week study, 10 patients discontinued prematurely, 
      including three due to adverse events (AEs). At week 48, plasma HIV-1 RNA was <50 
      copies/ml in 40 patients (78.4%). No patient experienced virological failure 
      (defined as HIV-1 RNA > or =50 copies/ml at two consecutive post-baseline 
      measurements) during the study. Immunologic control was maintained, with no 
      significant changes in CD4+ or CD8+ T-cell counts. A statistically significant 
      improvement from baseline in haemoglobin level was observed at week 48 (median 
      change 0.8 g/dl; p<0.001). There was also a statistically significant decrease in 
      total cholesterol concentration at week 48 (-26.0 mg/dl; p = 0.001) in a subset 
      of patients (n = 22) entering the study with elevated total cholesterol. 
      Treatment was well tolerated and no treatment-related grade 3 or 4 AEs were seen. 
      - CONCLUSIONS: Results from this study support switching from a 
      ZDV/3TC-containing HAART regimen to a completely QD regimen of TDF/FTC plus a 
      third agent. Virologic and immunologic control are maintained, with apparent 
      benefits in haemoglobin.
FAU - Arasteh, Keikawus
AU  - Arasteh K
AD  - Epimed, Berlin, Germany. keikawus.arasteh@vivantes.de
FAU - Weitner, L
AU  - Weitner L
FAU - Fenske, S
AU  - Fenske S
FAU - Kuhlmann, B
AU  - Kuhlmann B
FAU - Freiwald, M
AU  - Freiwald M
FAU - Ebrahimi, R
AU  - Ebrahimi R
FAU - Gallo, L
AU  - Gallo L
FAU - Ranneberg, R
AU  - Ranneberg R
FAU - Mertenskoetter, T
AU  - Mertenskoetter T
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Eur J Med Res
JT  - European journal of medical research
JID - 9517857
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Hemoglobins)
RN  - 0 (Organophosphonates)
RN  - 0 (RNA, Viral)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 4B9XT59T7S (Zidovudine)
RN  - 99YXE507IL (Tenofovir)
RN  - G70B4ETF4S (Emtricitabine)
RN  - JAC85A2161 (Adenine)
SB  - IM
MH  - Adenine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Adult
MH  - Aged
MH  - Anti-HIV Agents/*administration & dosage/adverse effects
MH  - Antiretroviral Therapy, Highly Active
MH  - Deoxycytidine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Emtricitabine
MH  - Female
MH  - HIV Infections/*drug therapy/virology
MH  - HIV-1/genetics/isolation & purification
MH  - Hemoglobins/analysis/drug effects
MH  - Humans
MH  - Lamivudine/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Organophosphonates/*administration & dosage/adverse effects
MH  - Prospective Studies
MH  - RNA, Viral/blood
MH  - Tenofovir
MH  - Treatment Outcome
MH  - Viral Load
MH  - Young Adult
MH  - Zidovudine/*administration & dosage/adverse effects
PMC - PMC3351977
EDAT- 2009/06/23 09:00
MHDA- 2009/07/08 09:00
PMCR- 2009/05/14
CRDT- 2009/06/23 09:00
PHST- 2009/06/23 09:00 [entrez]
PHST- 2009/06/23 09:00 [pubmed]
PHST- 2009/07/08 09:00 [medline]
PHST- 2009/05/14 00:00 [pmc-release]
AID - 2047-783X-14-5-195 [pii]
AID - 10.1186/2047-783x-14-5-195 [doi]
PST - ppublish
SO  - Eur J Med Res. 2009 May 14;14(5):195-9. doi: 10.1186/2047-783x-14-5-195.