PMID- 17554217
OWN - NLM
STAT- MEDLINE
DCOM- 20070827
LR  - 20201209
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 45
IP  - 4
DP  - 2007 Aug 1
TI  - Long-term efficacy and safety of tipranavir boosted with ritonavir in 
      HIV-1-infected patients failing multiple protease inhibitor regimens: 80-week 
      data from a phase 2 study.
PG  - 401-10
AB  - BACKGROUND: BI 1182.2, an open-label, randomized, multicenter, phase 2 study, 
      evaluated efficacy and tolerability of the protease inhibitor (PI) tipranavir 
      (TPV; 500 mg twice daily or 1000 mg twice daily) administered with ritonavir (100 
      mg twice daily) in combination with 1 nucleoside reverse transcriptase inhibitor 
      and 1 nonnucleoside reverse transcriptase inhibitor in multiple PI-experienced 
      HIV-1-infected patients. METHODS: Forty-one patients were evaluated in 2 arms: 
      low-dose (19 patients) or high-dose (22 patients) ritonavir-boosted tipranavir 
      (TPV/r). Primary endpoints were change from baseline in HIV-1 RNA concentrations 
      at weeks 16, 24, 48, and 80 and percentage of patients with plasma HIV-1 RNA 
      levels lower than the limit of quantitation. Safety was evaluated by adverse 
      events (AEs), grade 3/4 abnormalities, and serious AEs. RESULTS: Of all patients, 
      59% were still receiving TPV/r (14 in low-dose arm and 10 in high-dose arm) at 
      week 80. Patients in both arms had a median >2.0-log10 reduction in plasma viral 
      load. Intent-to-treat analysis demonstrated that a similar proportion of patients 
      in the high-dose and low-dose groups achieved plasma HIV-1 RNA levels <50 
      copies/mL at week 80 (43% vs. 32%; P = 0.527). The most frequently observed AEs 
      were diarrhea, headache, and nausea. CONCLUSION: TPV/r combined with other active 
      antiretroviral agents can provide a durable treatment response for highly 
      treatment-experienced patients.
FAU - Markowitz, Martin
AU  - Markowitz M
AD  - Aaron Diamond AIDS Research Center, Rockefeller University, 455 First Avenue, New 
      York, NY 10016, USA. mmarkowitz@adarc.org
FAU - Slater, Leonard N
AU  - Slater LN
FAU - Schwartz, Robert
AU  - Schwartz R
FAU - Kazanjian, Powel H
AU  - Kazanjian PH
FAU - Hathaway, Bruce
AU  - Hathaway B
FAU - Wheeler, David
AU  - Wheeler D
FAU - Goldman, Mitchell
AU  - Goldman M
FAU - Neubacher, Dietmar
AU  - Neubacher D
FAU - Mayers, Douglas
AU  - Mayers D
FAU - Valdez, Hernan
AU  - Valdez H
FAU - McCallister, Scott
AU  - McCallister S
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (Pyridines)
RN  - 0 (Pyrones)
RN  - 0 (RNA, Viral)
RN  - 0 (Reverse Transcriptase Inhibitors)
RN  - 0 (Sulfonamides)
RN  - O3J8G9O825 (Ritonavir)
RN  - ZZT404XD09 (tipranavir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Drug Therapy, Combination
MH  - Female
MH  - HIV Infections/*drug therapy/virology
MH  - HIV Protease Inhibitors/adverse effects/*therapeutic use
MH  - HIV-1/drug effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pyridines/administration & dosage/adverse effects/*therapeutic use
MH  - Pyrones/administration & dosage/adverse effects/*therapeutic use
MH  - RNA, Viral/blood
MH  - Reverse Transcriptase Inhibitors/administration & dosage/therapeutic use
MH  - Ritonavir/administration & dosage/adverse effects/*therapeutic use
MH  - Sulfonamides
MH  - Time Factors
MH  - Treatment Failure
MH  - Treatment Outcome
EDAT- 2007/06/08 09:00
MHDA- 2007/08/28 09:00
CRDT- 2007/06/08 09:00
PHST- 2007/06/08 09:00 [pubmed]
PHST- 2007/08/28 09:00 [medline]
PHST- 2007/06/08 09:00 [entrez]
AID - 10.1097/QAI.0b013e318074eff5 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2007 Aug 1;45(4):401-10. doi: 
      10.1097/QAI.0b013e318074eff5.