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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: AIDS Clinical Trials Group
• Treatments: Lopinavir; Ritonavir

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