Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043953
• Other study ID #: M01-384
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2002
• Last updated: September 26, 2007
• Start date: August 2002

Study information

• Verified date: September 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lopinavir/ritonavir

• Saquinavir mesylate

• Lamivudine/zidovudine

Locations

Country	Name	City	State
Canada	University of Ottawa Health Research Institute	Ottawa
Canada	University of Ottawa at the Ottawa Health Research Institute	Ottawa,
United States	Community Research Initiative of New England	Boston,	Massachusetts
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of North Carolina at Chapel Hill	Chapel Hill,	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	AHF Research	Los Angeles	California
United States	Pacific Horizon Medical Group	San Francisco	California
United States	Stephen Becker, MD	San Francisco,	California
United States	Community Research Initiative of New England	Springfield	Massachusetts
United States	Harbor UCLA, Research & Education Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with plasma HIV RNA level below 50 copies/mL		48 weeks