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CompletedNCT00143689Updated Sep 26, 2014

NRTI-Sparing Pilot Study

A Phase 4 interventional study of lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine in HIV and Mitochondrial Toxicity, sponsored by University of British Columbia. Completed at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-26.

Sponsored by University of British Columbia · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing) regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based regimens (Combivir + nevirapine and Combivir + Kaletra).

Participants will be randomly assigned to receive one of the following drug combinations:

  • lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
  • Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
  • Combivir and lopinavir/ritonavir twice a day.
02

Conditions studied

  • HIV
  • Mitochondrial Toxicity
03

In context

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Be HIV-positive
  • Be at least18 years of age
  • Have viral load above 5 000 copies/ml
  • Be likely to comply with the study protocol
  • Agree not to take, for the duration of the study, any drug that is contraindicated with the study drugs
  • Agree not to take any medication, including over-the-counter medicine, alcohol, or street drugs without the knowledge and permission of the principal investigator

Exclusion criteria

Exclusion Criteria:

  • Have ever received antiretroviral therapy
  • Pregnancy or breastfeeding
  • Have abnormal laboratory tests (see investigator)
  • Have received an investigational drug within 30 days of study drugs administration
  • Be receiving systemic chemotherapy
  • Have an acute illness
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Lopinavir/ritonavir, Zidovudine, Lamivudine

    Participants will be randomly assigned to receive one of the following drug combinations: * lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day; * Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day; * Combivir and lopinavir/ritonavir twice a day.

    Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine

Interventions

  • Druglopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine

    See Detailed Description.

06

What researchers measure

Primary outcomes

  1. Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.

    Time frame: 48 weeks

Secondary outcomes

  1. Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks

    Time frame: 96 weeks

  2. Proportions of patients with viral load below 50 and below 400 copies/mL

  3. Viral load changes from baseline

  4. Rates and extent of immune reconstitution (CD4 count increase)

  5. Rates and severity of dyslipidemia and insuline resistance/diabetes

07

Study locations

4 sites
  • McMaster University
    Hamilton, Ontario, Canada
  • University of Ottawa Health Services
    Ottawa, Ontario, Canada
  • Maple Leaf Clinic
    Toronto, Ontario, Canada
  • Clinique Medicale L'Actuel
    Montreal, Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00143689
Lead sponsor
University of British Columbia
Collaborators
Abbott, Boehringer Ingelheim, CIHR Canadian HIV Trials Network
Responsible party
Sponsor
First posted
Sep 2, 2005
Start date
Apr 2002
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Sep 26, 2014

Study contacts

Julio Montaner, MD
principal investigator · University of British Columbia/Providence Health Care
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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