Status:
COMPLETED
Differences in Blood Levels of Lopinavir/Ritonavir in HIV Infected Men and Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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/...
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. Ho...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00102986
Start Date
October 1 2005
End Date
July 1 2007
Last Update
December 3 2015
Active Locations (29)
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1
University of Southern California CRS
Los Angeles, California, United States, 90033-1079
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
3
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, United States, 94304-5350
4
UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103