Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Lopinavir/ritonavir (Drug); Saquinavir mesylate (Drug); Lamivudine/zidovudine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Barbara A da Silva, M.D., Study Director, Affiliation: Associate Medical Director, Antiviral Global Project Team
Summary
The objectives of this study are to explore the metabolic toxicities associated with
lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in
antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of
LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the
pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in
combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine
BID.
Clinical Details
Official title: A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of subjects with plasma HIV RNA level below 50 copies/mL
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is naïve to antiretroviral treatment (subjects may not have more than 7 days
of any antiretroviral treatment).
- Subject is at least 18 years of age, inclusive.
- If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy), or is of childbearing potential and practicing one of
the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or
intrauterine device(IUD), a vasectomized partner, total abstinence from sexual
intercourse
- If female, the results of a urine pregnancy test performed at screening (urine
specimen obtained no earlier than 28 days prior to study drug administration) is
negative.
- Subject is not breast-feeding.
- Vital signs, physical examination and laboratory results do not exhibit evidence of
acute illness.
- Subject has no significant history of cardiac, renal, neurologic, psychiatric,
oncologic, endocrinologic, metabolic or hepatic disease that would in the opinion of
the investigator adversely affect his/her participating in this study.
- Subject does not require and agrees not to take any of the following medications for
the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride,
pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine,
dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin,
simvastatin, and St. John's wort.
- Subject agrees not to take any medication during the study, including
over-the-counter medicine, alcohol or recreational drugs without the knowledge and
permission of the principal investigator.
- Subject has not been treated for an active AIDS-defining opportunistic infection
within 30 days of screening.
- Subject has a plasma HIV RNA level of greater than 400 copies/mL at screening.
- Subject agrees to take all doses of the study drug from the bottles provided by the
sponsor (rather than other containers, i. e., "pill box").
- Subject has voluntarily signed and dated an informed consent form, approved by an
Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature
of the study has been explained and the subject has had the opportunity to ask
questions. The informed consent must be signed before any study-specific procedures
are performed.
Exclusion Criteria:
- Subject has a history of an allergic reaction or significant sensitivity to LPV/r,
INV or Combivir.
- Subject has a history of substance abuse or psychiatric illness that could preclude
adherence with the protocol.
- Screening laboratory analyses show any of the following abnormal laboratory results:
- Hemoglobin ≤ 10. 0 g/dL
- Absolute neutrophil count ≤ 1000 cells/µL
- Platelet count ≤ 50,000 per mL
- ALT or AST ≥ 3. 0 x Upper Limit of Normal (ULN)
- Creatinine ≥ 1. 5 x Upper Limit of Normal (ULN)
- Subject has received any investigational drug within 30 days prior to study drug
administration.
- For any reason, subject is considered by the investigator to be an unsuitable
candidate for the study.
Locations and Contacts
University of Ottawa at the Ottawa Health Research Institute, Ottawa, K1H 8L6, Canada
University of Ottawa Health Research Institute, Ottawa K1H 8L6, Canada
AHF Research, Los Angeles, California 90015, United States
Stephen Becker, MD, San Francisco,, California 94115, United States
Pacific Horizon Medical Group, San Francisco, California 94115, United States
Harbor UCLA, Research & Education Institute, Torrance, California 90502, United States
Community Research Initiative of New England, Boston,, Massachusetts 02215, United States
Community Research Initiative of New England, Springfield, Massachusetts 01107, United States
University of North Carolina at Chapel Hill, Chapel Hill,, North Carolina 27599, United States
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7215, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: August 2002
Last updated: September 26, 2007
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