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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00102986

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

116

Starts

2005-10-01

Expected to finish

2007-07-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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