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Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Intervention: Atazanavir + Ritonavir + Combivir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.

Clinical Details

Official title: A Study of the Pharmacokinetics of Atazanavir (ATV)/Ritonavir(RTV) Administered as Part of Highly Active Antiretroviral Therapy (HAART) in HIV-1 Infected Pregnant Women

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Infant Gestational Age at Delivery

Infant Gender

Infant Race

Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval

Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval

Mean ATV Area Under the Concentration Curve (AUC TAU)

Mean RTV Area Under the Concentration Curve (AUC TAU)

Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose

Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose

Mean ATV Terminal Elimination Half Life (T 1/2)

Mean RTV Terminal Elimination Half Life (T 1/2)

Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)

Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)

Secondary outcome:

Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery

Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level

Mean HIV RNA Level at Baseline

Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count

Mean CD4 Cell Count at Baseline

Infant HIV Status

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Grade 2 to Grade 4 AEs and SAEs

SAEs in Enrolled Mothers

SAEs in Enrolled Infants

Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration

Median Infant Total Bilirubin Level

Mean Atazanavir Plasma Protein Binding

Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- HIV-infected pregnant women

- > 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

Locations and Contacts

Local Institution, San Juan 00936, Puerto Rico

Triple O Medical Services, P.A., West Palm Beach, Florida 33401, United States

Local Institution, Soweto, Gauteng 2001, South Africa

Local Institution, Sunnyside, Gauteng 0002, South Africa

Local Institution, Westdene, Gauteng 2092, South Africa

Women's Hospital Of Texas, Houston, Texas 77054, United States

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2006
Last updated: November 4, 2011

Page last updated: August 23, 2015

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