Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women
NCT ID: NCT00326716
Last Updated: 2011-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2006-06-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Atazanavir + Ritonavir + Combivir
Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks
Interventions
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Atazanavir + Ritonavir + Combivir
Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \> 18 years of age
* Between week 12 and 32 gestation
* CD4 \> 200 cells/mm³
* Treatment-naive with HIV RNA \> 400 c/mL, on HAART with HIV RNA \<50 c/mL, or previously treated with ATV (\< 3 weeks) with HIV RNA\>400 c/mL
18 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Triple O Medical Services, P.A.
West Palm Beach, Florida, United States
Women's Hospital Of Texas
Houston, Texas, United States
Local Institution
San Juan, , Puerto Rico
Local Institution
Soweto, Gauteng, South Africa
Local Institution
Sunnyside, Gauteng, South Africa
Local Institution
Westdene, Gauteng, South Africa
Countries
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References
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Xu XS, Rose A, Demers R, Eley T, Ryan J, Stouffer B, Cojocaru L, Arnold M. Quantitative determination of free/bound atazanavir via high-throughput equilibrium dialysis and LC-MS/MS, and the application in ex vivo samples. Bioanalysis. 2014;6(23):3169-82. doi: 10.4155/bio.14.251.
Eley T, Huang SP, Conradie F, Zorrilla CD, Josipovic D, Botes M, Osiyemi O, Hardy H, Bertz R, McGrath D. Clinical and pharmacogenetic factors affecting neonatal bilirubinemia following atazanavir treatment of mothers during pregnancy. AIDS Res Hum Retroviruses. 2013 Oct;29(10):1287-92. doi: 10.1089/AID.2013.0002. Epub 2013 Jul 19.
Conradie F, Zorrilla C, Josipovic D, Botes M, Osiyemi O, Vandeloise E, Eley T, Child M, Bertz R, Hu W, Wirtz V, McGrath D. Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women. HIV Med. 2011 Oct;12(9):570-9. doi: 10.1111/j.1468-1293.2011.00927.x. Epub 2011 May 16.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI424-182
Identifier Type: -
Identifier Source: org_study_id