NCT00043953

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2002

Completed
Last Updated

September 27, 2007

Status Verified

September 1, 2007

First QC Date

August 15, 2002

Last Update Submit

September 26, 2007

Conditions

HIV Infections

Keywords

treatment naive

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with plasma HIV RNA level below 50 copies/mL

    48 weeks

Interventions

Lopinavir/ritonavirDRUG
Saquinavir mesylateDRUG
Lamivudine/zidovudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

AHF Research

Los Angeles, California, 90015, United States

Location

Pacific Horizon Medical Group

San Francisco, California, 94115, United States

Location

Stephen Becker, MD

San Francisco, California, 94115, United States

Location

Harbor UCLA, Research & Education Institute

Torrance, California, 90502, United States

Location

Community Research Initiative of New England

Boston, Massachusetts, 02215, United States

Location

Community Research Initiative of New England

Springfield, Massachusetts, 01107, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7215, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Ottawa at the Ottawa Health Research Institute

Ottawa, K1H 8L6, Canada

Location

University of Ottawa Health Research Institute

Ottawa, K1H 8L6, Canada

Location

MeSH Terms

Conditions

HIV Infections

Interventions

LopinavirSaquinavirlamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinolines

Study Officials

  • Barbara A da Silva, M.D.

    Associate Medical Director, Antiviral Global Project Team

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2002

First Posted

August 19, 2002

Study Start

August 1, 2002

Last Updated

September 27, 2007

Record last verified: 2007-09

Locations

CA(2)US(9)