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Ensayos clínicos

Ensayos clínicos

Differences in Blood Levels of Lopinavir/Ritonavir in HIV Infected Men and Women

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00102986, ACTG A5223
  • Concluido

Propósito del estudio

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.

Afección:
Infecciones por el VIH

Detalles del estudio

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.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.

Criterios de inclusión

    Note: Step 1 enrollment ended as of 06/28/06.
    • 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

Criterios de exclusión

    :
    • 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

Centros de estudio/contactos

California

    USC CRS, Los Angeles, California, 90033, United States

    UCLA CARE Center CRS, Los Angeles, California, 90035, United States

    Stanford CRS, Palo Alto, California, 94304-5350, United States

    Ucsd, Avrc Crs, San Diego, California, 92103, United States

    Harbor-UCLA Med. Ctr. CRS, Torrance, California, 90502, United States

Colorado

    University of Colorado Hospital CRS, Aurora, Colorado, 80045, United States

District of Columbia

    Georgetown University CRS (GU CRS), Washington, District of Columbia, 20007, United States

Florida

    Univ. of Miami AIDS CRS, Miami, Florida, 33136, United States

Hawaii

    Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii, 96816, United States

Illinois

    Cook County Hosp. CORE Ctr., Chicago, Illinois, 60612, United States

    Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois, 60612, United States

Indiana

    Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana, 46202-5250, United States

Maryland

    Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, 21287, United States

Massachusetts

    Bmc Actg Crs, Boston, Massachusetts, 02118, United States

Missouri

    Washington U CRS, St. Louis, Missouri, 63110, United States

New York

    Beth Israel Med. Ctr., ACTU, New York, New York, 10003, United States

    HIV Prevention & Treatment CRS, New York, New York, 10032, United States

    NY Univ. HIV/AIDS CRS, New York, New York, 10016, United States

    Univ. of Rochester ACTG CRS, Rochester, New York, 14642, United States

North Carolina

    Unc Aids Crs, Chapel Hill, North Carolina, 27514, United States

Ohio

    Univ. of Cincinnati CRS, Cincinnati, Ohio, 45267-0405, United States

    MetroHealth CRS, Cleveland, Ohio, 44109, United States

    The Ohio State University Medical Center, Columbus, Ohio, 43210, United States

Pennsylvania

    Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania, 19104, United States

    Pitt CRS, Pittsburgh, Pennsylvania, 15213-2582, United States

Tennessee

    Vanderbilt Therapeutics CRS, Nashville, Tennessee, 37204, United States

Texas

    Univ. of Texas Medical Branch, ACTU, Galveston, Texas, 77555-0435, United States

Washington

    University of Washington AIDS CRS, Seattle, Washington, 98104, United States

    Puerto Rico-AIDS CRS, San Juan, Washington, 00935, Puerto Rico

Actualizado: 8 de noviembre del 2006

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