Differences in Blood Levels of Lopinavir/Ritonavir in HIV Infected Men and Women
NCT ID: NCT00102986
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2005-10-31
2007-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Lopinavir/ritonavir
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Judith S. Currier, MD, MSc
Role: STUDY_CHAIR
Center for AIDS Research and Education, University of California, Los Angeles
Locations
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University of Southern California CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, United States
UCSD Antiviral Research Center CRS
San Diego, California, United States
Harbor-UCLA CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Georgetown University CRS (GU CRS)
Washington D.C., District of Columbia, United States
The University of Miami AIDS Clinical Research Unit (ACRU) CRS
Miami, Florida, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Rush University CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 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
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Cincinnati CRS
Cincinnati, Ohio, United States
MetroHealth CRS
Cleveland, Ohio, United States
Ohio State University CRS
Columbus, Ohio, United States
Penn Therapeutics, CRS
Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Puerto Rico AIDS Clinical Trials Unit CRS
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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ACTG A5223
Identifier Type: -
Identifier Source: secondary_id
10026
Identifier Type: REGISTRY
Identifier Source: secondary_id
A5223
Identifier Type: -
Identifier Source: org_study_id