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

December 2, 2015 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Sex Differences in Lopinavir/Ritonavir Pharmacokinetics Among HIV-1-Infected Men and Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Puerto Rico AIDS Clinical Trials Unit CRS
  • United States
    • California
      • Los Angeles, California, United States, 90035
        • UCLA CARE Center CRS
      • Los Angeles, California, United States, 90033-1079
        • University of Southern California CRS
      • Palo Alto, California, United States, 94304-5350
        • Stanford AIDS Clinical Trials Unit CRS
      • San Diego, California, United States, 92103
        • UCSD Antiviral Research Center CRS
      • Torrance, California, United States, 90502
        • Harbor-UCLA CRS
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital CRS
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University CRS (GU CRS)
    • Florida
      • Miami, Florida, United States, 33136
        • The University of Miami AIDS Clinical Research Unit (ACRU) CRS
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ. of Hawaii at Manoa, Leahi Hosp.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp. CORE Ctr.
      • Chicago, Illinois, United States, 60612
        • Rush University CRS
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5250
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Bmc Actg Crs
    • Missouri
      • St. Louis, Missouri, United States, 63110-1010
        • Washington University Therapeutics (WT) CRS
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med. Ctr., ACTU
      • New York, New York, United States, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, United States, 10032-3732
        • Columbia P&S CRS
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Chapel Hill CRS
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Cincinnati CRS
      • Cleveland, Ohio, United States, 44109
        • MetroHealth CRS
      • Columbus, Ohio, United States, 43210
        • Ohio State University CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Therapeutics, CRS
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh CRS
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt Therapeutics (VT) CRS
    • Texas
      • Galveston, Texas, United States, 77555-0435
        • Univ. of Texas Medical Branch, ACTU
    • Washington
      • Seattle, Washington, United States, 98104-9929
        • University of Washington AIDS CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours

Secondary Outcome Measures

Outcome Measure
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

AIDS Clinical Trials Group

Investigators

  • Study Chair: Judith S. Currier, MD, MSc, Center for AIDS Research and Education, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 4, 2005

First Submitted That Met QC Criteria

February 4, 2005

First Posted (Estimate)

February 7, 2005

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5223
  • 10026 (Other Identifier: CTEP)
  • ACTG A5223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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