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 lopinavir/ritonavir (LPV/r) in HIV infected men and women.

Study hypothesis: Women achieve higher LPV drug levels than do men on similar doses of LPV.

Condition	Treatment or Intervention
HIV Infections	Drug: Lopinavir/ritonavir

Further Study Details: 

Primary Outcomes: Lopinavir area under the concentration-time curve (AUC) for 0 to 12 hours compared between HIV infected men and women
Expected Total Enrollment:  78

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 antiretroviral drugs used in the treatment of HIV are from studies conducted primarily in men. This study will determine the differences in LPV/r pharmacokinetics (PK) in men and women.

No antiretrovirals will be provided by this study. During the study, participants will take a treatment regimen of LPV/r twice daily and one or more of the following: a nucleoside reverse transcriptase inhibitor, tenofovir disoproxil fumarate, or enfuvirtide. Medical and medication history, blood collection, and clinical assessments will occur at study screening. Participants 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• HIV infected
• Have taken LPV/r twice daily for at least 14 days immediately prior to study screening and are willing to continue taking LPV/r until the PK visit
• Have taken LPV/r in combination with at least one of the following for at least 14 days immediately prior to screening: zidovudine, lamivudine, emtricitabine, stavudine, abacavir sulfate, didanosine, zalcitabine, tenofovir disoproxil fumarate, enfuvirtide, AND are willing to continue taking them until the PK visit
• Body weight of more than 50 kg (110 lbs)

Exclusion Criteria:

• Nonnucleoside reverse transcriptase inhibitor or dual protease inhibitor regimen within 30 days prior to study entry
• 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

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35924-2050,  United States
California
      Stanford University, Stanford,  California,  94305-5107,  United States
      University of Southern California, Los Angeles,  California,  90033-1079,  United States
Indiana
      Indiana University Hospital, Indianapolis,  Indiana,  46202-5250,  United States
      Methodist Hospital of Indiana, Indianapolis,  Indiana,  46202-5250,  United States
      Wishard Hospital, Indianapolis,  Indiana,  46202,  United States
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287-8106,  United States
      University of Maryland, Institute of Human Virology, Baltimore,  Maryland,  21201,  United States
New York
      Beth Israel Medical Center, New York,  New York,  10003,  United States
      University of Rochester Medical Center, Rochester,  New York,  14642-0001,  United States
Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2582,  United States
      University of Pennsylvania, Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
Texas
      University of Texas, Galveston, Galveston,  Texas,  77555-0435,  United States

Study chairs or principal investigators

Judith S. Currier, MD, MSc,  Study Chair,  Center for AIDS Research and Education, University of California, Los Angeles   

Study ID Numbers:  ACTG A5223
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  February 4, 2005
ClinicalTrials.gov Identifier:  NCT00102986
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08