HIV Infections
Conditions
Keywords
Kaletra, Treatment Experienced
Brief 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.
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.
Interventions
DRUGLopinavir/ritonavir
Sponsors
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 maximum concentration (Cmax), concentration at 12 hours (C12h), and apparent oral clearance (CL/F) | — |
| 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 | — |
| 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) | — |
Countries
Puerto Rico, United States
Outcome results
None listed