PMID- 23466649
OWN - NLM
STAT- MEDLINE
DCOM- 20131111
LR  - 20220330
IS  - 1944-7884 (Electronic)
IS  - 1525-4135 (Linking)
VI  - 64
IP  - 1
DP  - 2013 Sep 1
TI  - Randomized trial of clinical safety of daily oral tenofovir disoproxil fumarate 
      among HIV-uninfected men who have sex with men in the United States.
PG  - 79-86
LID - 10.1097/QAI.0b013e31828ece33 [doi]
AB  - OBJECTIVES: To evaluate the clinical safety of daily tenofovir disoproxil 
      fumarate (TDF) among HIV-negative men who have sex with men. DESIGN: Randomized, 
      double-blind, placebo-controlled trial. Participants were randomized 1:1:1:1 to 
      immediate or delayed study drug (TDF, 300 mg orally per day, or placebo). 
      METHODS: Four hundred healthy HIV-uninfected men who have sex with men reporting 
      anal sex with another man within the previous 12 months enrolled in Atlanta, 
      Boston, and San Francisco. HIV serostatus, clinical and laboratory adverse events 
      (AEs), adherence (pill count, Medication Event Monitoring System, and 
      self-report), and sexual and other sociobehavioral data were assessed at 3-month 
      intervals for 24 months. Primary outcomes were clinical safety, assessed by 
      incidence of AEs and laboratory abnormalities. RESULTS: Study drug was initiated 
      by 373 (93%) participants (186 TDF and 187 placebo), of whom 325 (87%) completed 
      the final study visit. Of 2428 AEs reported among 334 (90%) participants, 2366 
      (97%) were mild or moderate in severity. Frequencies of commonly reported AEs did 
      not differ significantly between TDF and placebo arms. In multivariable analyses, 
      back pain was more likely among TDF recipients (P = 0.04); these reports were not 
      associated with documented fractures or other objective findings. There were no 
      grade >/=3 creatinine elevations; grades 1 and 2 creatinine increases were not 
      associated with TDF receipt. Estimated percentage of study drug doses taken was 
      92% by pill count and 77% by Medication Event Monitoring System. Seven 
      seroconversions occurred: 4 on placebo and 3 among delayed arm participants not 
      yet on study drug. CONCLUSIONS: Daily oral TDF was well tolerated, with 
      reasonable adherence. No significant renal concerns were identified.
FAU - Grohskopf, Lisa A
AU  - Grohskopf LA
AD  - Epidemiology Branch, Division of HIV/AIDS Prevention, Centers for Disease Control 
      and Prevention, Atlanta, GA, USA. lkg6@cdc.gov
FAU - Chillag, Kata L
AU  - Chillag KL
FAU - Gvetadze, Roman
AU  - Gvetadze R
FAU - Liu, Albert Y
AU  - Liu AY
FAU - Thompson, Melanie
AU  - Thompson M
FAU - Mayer, Kenneth H
AU  - Mayer KH
FAU - Collins, Brandi M
AU  - Collins BM
FAU - Pathak, Sonal R
AU  - Pathak SR
FAU - O'hara, Brandon
AU  - O'hara B
FAU - Ackers, Marta L
AU  - Ackers ML
FAU - Rose, Charles E
AU  - Rose CE
FAU - Grant, Robert M
AU  - Grant RM
FAU - Paxton, Lynn A
AU  - Paxton LA
FAU - Buchbinder, Susan P
AU  - Buchbinder SP
LA  - eng
GR  - 200-2003-03003/PHS HHS/United States
GR  - 200-2003-03007/PHS HHS/United States
GR  - 200-2004-09853/PHS HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Organophosphonates)
RN  - 99YXE507IL (Tenofovir)
RN  - JAC85A2161 (Adenine)
SB  - IM
MH  - Adenine/administration & dosage/*analogs & derivatives/pharmacology
MH  - Adolescent
MH  - Anti-HIV Agents/*administration & dosage/pharmacology
MH  - Boston/epidemiology
MH  - CD4 Lymphocyte Count
MH  - Double-Blind Method
MH  - Follow-Up Studies
MH  - Georgia/epidemiology
MH  - HIV Infections/epidemiology/*prevention & control
MH  - *HIV Seronegativity
MH  - Homosexuality, Male/*statistics & numerical data
MH  - Humans
MH  - Hypophosphatemia/chemically induced
MH  - Male
MH  - Medication Adherence/*statistics & numerical data
MH  - Middle Aged
MH  - Organophosphonates/*administration & dosage/pharmacology
MH  - San Francisco/epidemiology
MH  - Tenofovir
MH  - Treatment Outcome
EDAT- 2013/03/08 06:00
MHDA- 2013/11/12 06:00
CRDT- 2013/03/08 06:00
PHST- 2013/03/08 06:00 [entrez]
PHST- 2013/03/08 06:00 [pubmed]
PHST- 2013/11/12 06:00 [medline]
AID - 10.1097/QAI.0b013e31828ece33 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2013 Sep 1;64(1):79-86. doi: 
      10.1097/QAI.0b013e31828ece33.