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Home > Clinical Trials > Treatment Experienced Bristol-Meyers Squibb (BMS) Study
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Clinical Trials

Treatment Experienced Bristol-Meyers Squibb (BMS) Study

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This is a phase IIb randomized, controlled, partially-blinded trial to investigate safety, efficacy, and dose-response of BMS-663068 in tx experienced HIV-1 subjects, followed by an open-label period on the recommended dose.

There will be five treatment groups, randomized 1:1:1:1:1 (50 in each group). Study is partially blinded through week 24 (for all subjects).

Stage 1 is 96 weeks in duration. Stage 2 extends the study to acquire longer-term safety and efficacy data. The post-dosing follow-up phase is 24 weeks in duration.

Treatment group 1: BMS-663068 400 mg BID + Ralt + TDF
Treatment group 2: BMS-663068 800 mg BID + Ralt + TDF
Treatment group 3: BMS- 663068 600 mg QD + Ralt +TDF
Treatment group 4: BMS- 663068 1200 mg QD + RAlt + TDF
Treatment group 5 (reference group): ATV/r 300/100 mg QD + Ralt +TDF

Inclusion Criteria

  • HIV RNA > 1,000
  • Treatment experiencedSusceptibility to study drugs
  • CD4 > 50

Exclusion Criteria

  • Chronic hep B / hep C
  • History of resistance to any component of the study regimen (TDF, ATV, RAL)

All HIV medications areprovided through study.

For more information, contact Vicky Pena at 919-668-0166.


(REF# 31249)
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Updated: Nov. 22, 2011
Published: Nov. 22, 2011
URL: http://www.dukehealth.org/clinicaltrials/treatment-experienced-bristol-meyers-squibb-bms-study