Differences in Blood Levels of Lopinavir/Ritonavir in HIV Infected Men and Women
- Conditions
- HIV Infections
- Registration Number
- NCT00102986
- 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.
- Detailed Description
It is estimated that 50% of people living with HIV/AIDS worldwide are women. HIV infected women face different psychosocial issues than men, and their bodies may react differently to HIV treatment. However, most of the data on the safety and efficacy of antiretrovirals (ARVs) used in the treatment of HIV infection are from studies conducted primarily in men. LPV/r in tablet form was approved by the FDA in October 2005. This study will determine the differences in pharmacokinetics (PK) in men and women taking a soft gel capsule and a tablet formulation of LPV/r.
No ARVs will be provided by this study. In Step 1, participants will receive soft gel capsules of LPV/r. All Step 1 participants will be asked to join Step 2 of the study upon completion of Step 1. In Step 2, participants will receive tablets of LPV/r. During the study, participants in both Step 1 and 2 will take a treatment regimen of LPV/r twice daily and one or more of the following: a nucleoside reverse transcriptase inhibitor (NRTI), tenofovir disoproxil fumarate, or enfuvirtide. Medical and medication history, blood collection, and clinical assessments will occur at study screening for both Steps 1 and 2. Participants in both steps will be asked to complete a medication diary from study entry to the day of the PK visit. The PK visit will occur within 30 days of study screening; blood collection for PK analysis will also occur at this visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours
- Secondary Outcome Measures
Name Time Method 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) ritonavir (RTV) AUC for 0 to 12 hours, Cmax, C12h, and CL/F LPV/r AUC for 0 to 12 hours, Cmax, C12h, CL/F for both the soft gel capsule and tablet formulations 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
Trial Locations
- Locations (29)
Harbor-UCLA CRS
🇺🇸Torrance, California, United States
Penn Therapeutics, CRS
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS
🇺🇸Pittsburgh, Pennsylvania, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
UCSD Antiviral Research Center CRS
🇺🇸San Diego, California, United States
The University of Miami AIDS Clinical Research Unit (ACRU) CRS
🇺🇸Miami, Florida, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Beth Israel Med. Ctr., ACTU
🇺🇸New York, New York, United States
Puerto Rico AIDS Clinical Trials Unit CRS
🇵🇷San Juan, Puerto Rico
Stanford AIDS Clinical Trials Unit CRS
🇺🇸Palo Alto, California, United States
Johns Hopkins University CRS
🇺🇸Baltimore, Maryland, United States
Univ. of Texas Medical Branch, ACTU
🇺🇸Galveston, Texas, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Washington University Therapeutics (WT) CRS
🇺🇸St. Louis, Missouri, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Columbia P&S CRS
🇺🇸New York, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
University of Southern California CRS
🇺🇸Los Angeles, California, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Georgetown University CRS (GU CRS)
🇺🇸Washington, District of Columbia, United States
Rush University CRS
🇺🇸Chicago, Illinois, United States
Chapel Hill CRS
🇺🇸Chapel Hill, North Carolina, United States
Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Ohio State University CRS
🇺🇸Columbus, Ohio, United States
Vanderbilt Therapeutics (VT) CRS
🇺🇸Nashville, Tennessee, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States