NRTI-Sparing Pilot Study | NCT00143689

Studies
NRTI-Sparing Pilot Study

NCT00143689

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Sep 26, 2014Estimated

Enrollment

13Actual

Phase

Phase 4

Conditions

HIV
Mitochondrial Toxicity

Interventions

lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CTN 177

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Aug 31, 2005

First Submission Date that Met QC Criteria

Aug 31, 2005

First Posted Date

Sep 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2014

Last Update Posted Date

Sep 26, 2014Estimated

Name	Class
Abbott	INDUSTRY
Boehringer Ingelheim	INDUSTRY
CIHR Canadian HIV Trials Network	NETWORK

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine	Drug	See Detailed Description.	Lopinavir/ritonavir, Zidovudine, Lamivudine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julio Montaner, MD	University of British Columbia/Providence Health Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster University		Hamilton	Ontario		Canada
University of Ottawa Health Services

Intervention Browse Module

MeSH Terms

ID	Term
D061466	Lopinavir
D019438	Ritonavir
D019829	Nevirapine
D015215	Zidovudine
D019259	Lamivudine

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

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