NCT00143689

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_4 hiv

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_4 hiv

Geographic Reach
1 country

4 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

April 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

5.8 years

First QC Date

August 31, 2005

Last Update Submit

September 25, 2014

Conditions

HIVMitochondrial Toxicity

Outcome Measures

Primary Outcomes (1)

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

    48 weeks

Secondary Outcomes (5)

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

    96 weeks

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

  • Viral load changes from baseline

  • Rates and extent of immune reconstitution (CD4 count increase)

  • Rates and severity of dyslipidemia and insuline resistance/diabetes

Study Arms (1)

Lopinavir/ritonavir, Zidovudine, Lamivudine

EXPERIMENTAL

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

lopinavir/ritonavir; nevirapine; Zidovudine; LamivudineDRUG

See Detailed Description.

Lopinavir/ritonavir, Zidovudine, Lamivudine

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

McMaster University

Hamilton, Ontario, Canada

Location

University of Ottawa Health Services

Ottawa, Ontario, Canada

Location

Maple Leaf Clinic

Toronto, Ontario, Canada

Location

Clinique Medicale L'Actuel

Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

LopinavirRitonavirNevirapineZidovudineLamivudine

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesPyridinesThymidinePyrimidine NucleosidesDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesZalcitabineDeoxycytidineCytidine

Study Officials

  • Julio Montaner, MD

    University of British Columbia/Providence Health Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

April 1, 2002

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 26, 2014

Record last verified: 2014-09

Locations

CA(4)