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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

Page last updated: August 23, 2015

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