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NCT00102986 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00102986
Other study ID # A5223
Secondary ID ACTG A522310026
Status Completed
Phase N/A
First received February 4, 2005
Last updated December 2, 2015
Start date October 2005
Est. completion date July 2007

Study information
Verified date December 2015
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 116
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lopinavir/ritonavir

Locations
Country Name City State
Puerto Rico Puerto Rico AIDS Clinical Trials Unit CRS San Juan
United States University of Colorado Hospital CRS Aurora Colorado
United States Johns Hopkins University CRS Baltimore Maryland
United States Bmc Actg Crs Boston Massachusetts
United States Chapel Hill CRS Chapel Hill North Carolina
United States Cook County Hosp. CORE Ctr. Chicago Illinois
United States Rush University CRS Chicago Illinois
United States Cincinnati CRS Cincinnati Ohio
United States MetroHealth CRS Cleveland Ohio
United States Ohio State University CRS Columbus Ohio
United States Univ. of Texas Medical Branch, ACTU Galveston Texas
United States Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii
United States Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana
United States UCLA CARE Center CRS Los Angeles California
United States University of Southern California CRS Los Angeles California
United States The University of Miami AIDS Clinical Research Unit (ACRU) CRS Miami Florida
United States Vanderbilt Therapeutics (VT) CRS Nashville Tennessee
United States Beth Israel Med. Ctr., ACTU New York New York
United States Columbia P&S CRS New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States Stanford AIDS Clinical Trials Unit CRS Palo Alto California
United States Penn Therapeutics, CRS Philadelphia Pennsylvania
United States University of Pittsburgh CRS Pittsburgh Pennsylvania
United States Univ. of Rochester ACTG CRS Rochester New York
United States UCSD Antiviral Research Center CRS San Diego California
United States University of Washington AIDS CRS Seattle Washington
United States Washington University Therapeutics (WT) CRS St. Louis Missouri
United States Harbor-UCLA CRS Torrance California
United States Georgetown University CRS (GU CRS) Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Group

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Umeh OC, Currier JS. Sex Differences in HIV: Natural History, Pharmacokinetics, and Drug Toxicity. Curr Infect Dis Rep. 2005 Jan;7(1):73-78. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours
Secondary LPV maximum concentration (Cmax), concentration at 12 hours (C12h), and apparent oral clearance (CL/F)
Secondary LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and participant's race and ethnicity
Secondary LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, participant's age, weight, and body mass index (BMI), and coadministration of TDF
Secondary LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded signs and symptoms
Secondary 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)
Secondary ritonavir (RTV) AUC for 0 to 12 hours, Cmax, C12h, and CL/F
Secondary LPV/r AUC for 0 to 12 hours, Cmax, C12h, CL/F for both the soft gel capsule and tablet formulations
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