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

This study has been completed.
Sponsor:
Collaborator:
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00102986
First received: February 4, 2005
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Lopinavir/ritonavir

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sex Differences in Lopinavir/Ritonavir Pharmacokinetics Among HIV-1-Infected Men and Women

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours

Secondary Outcome Measures:
  • 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

Enrollment: 116
Study Start Date: October 2005
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102986

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

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00102986     History of Changes
Other Study ID Numbers: A5223, ACTG A5223, 10026
Study First Received: February 4, 2005
Last Updated: August 12, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kaletra
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014