Differences in Blood Levels of Lopinavir/Ritonavir in HIV Infected Men and Women
Sex Differences in Lopinavir/Ritonavir Pharmacokinetics Among HIV-1-Infected Men and Women
3 other identifiers
interventional
116
2 countries
29
Brief Summary
Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavir/ritonavir (LPV/r) in HIV infected men and women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Oct 2005
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2005
CompletedFirst Posted
Study publicly available on registry
February 7, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 3, 2015
December 1, 2015
February 4, 2005
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours
Secondary Outcomes (7)
LPV maximum concentration (Cmax), concentration at 12 hours (C12h), and apparent oral clearance (CL/F)
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and participant's race and ethnicity
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, participant's age, weight, and body mass index (BMI), and coadministration of TDF
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded signs and symptoms
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded gastrointestinal signs and symptoms (defined as nausea, vomiting, diarrhea, abdominal pain, and bloating)
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- Have taken twice-daily LPV/r (soft gel formulation for Step 1 participants and tablet formulation for Step 2 participants) for at least 14 days immediately prior to step screening and are willing to continue taking LPV/r until the PK visit of that step
- Have taken LPV/r in combination with at least one of the following for at least 14 days immediately prior to study step screening: zidovudine, lamivudine, emtricitabine, stavudine, abacavir sulfate, didanosine, zalcitabine, tenofovir disoproxil fumarate, enfuvirtide, AND are willing to continue taking them until the PK visit of that step
- Body weight of more than 50 kg (110 lbs) for Step 1 participants only
You may not qualify if:
- Non-nucleoside reverse transcriptase inhibitor or dual protease inhibitor regimen within 30 days prior to study entry
- Require certain medications
- Current drug or alcohol abuse that, in the investigator's opinion, may interfere with the study
- Serious illness requiring systemic treatment or hospitalization within 30 days of study screening
- Acute AIDS-related opportunistic infection within 90 days of study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
University of Southern California CRS
Los Angeles, California, 90033-1079, United States
UCLA CARE Center CRS
Los Angeles, California, 90035, United States
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, 94304-5350, United States
UCSD Antiviral Research Center CRS
San Diego, California, 92103, United States
Harbor-UCLA CRS
Torrance, California, 90502, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80045, United States
Georgetown University CRS (GU CRS)
Washington D.C., District of Columbia, 20007, United States
The University of Miami AIDS Clinical Research Unit (ACRU) CRS
Miami, Florida, 33136, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612, United States
Rush University CRS
Chicago, Illinois, 60612, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202-5250, United States
Johns Hopkins University CRS
Baltimore, Maryland, 21205, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Washington University Therapeutics (WT) CRS
St Louis, Missouri, 63110-1010, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Columbia P&S CRS
New York, New York, 10032-3732, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Chapel Hill CRS
Chapel Hill, North Carolina, 27599, United States
Cincinnati CRS
Cincinnati, Ohio, 45219, United States
MetroHealth CRS
Cleveland, Ohio, 44109, United States
Ohio State University CRS
Columbus, Ohio, 43210, United States
Penn Therapeutics, CRS
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, 37204, United States
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 77555-0435, United States
University of Washington AIDS CRS
Seattle, Washington, 98104-9929, United States
Puerto Rico AIDS Clinical Trials Unit CRS
San Juan, 00935, Puerto Rico
Related Publications (1)
Umeh OC, Currier JS. Sex Differences in HIV: Natural History, Pharmacokinetics, and Drug Toxicity. Curr Infect Dis Rep. 2005 Jan;7(1):73-78. doi: 10.1007/s11908-005-0026-9.
PMID: 15610674BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Judith S. Currier, MD, MSc
Center for AIDS Research and Education, University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2005
First Posted
February 7, 2005
Study Start
October 1, 2005
Study Completion
July 1, 2007
Last Updated
December 3, 2015
Record last verified: 2015-12