NRTI-Sparing Pilot Study

NCT00143689 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2014-09-26

No results posted yet for this 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.

Conditions

  • HIV
  • Mitochondrial Toxicity

Interventions

DRUG

lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine

See Detailed Description.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY
  • Boehringer Ingelheim

    collaborator INDUSTRY
  • CIHR Canadian HIV Trials Network

    collaborator NETWORK
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Julio Montaner, MD · University of British Columbia/Providence Health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00143689 on ClinicalTrials.gov