HIVPhase 4NCT00143689
NRTI-Sparing Pilot Study
A Phase 4 study testing lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine in people with HIV and Mitochondrial Toxicity, run by University of British Columbia at 4 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Mitochondrial Toxicity
- What is being tested?
- lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesCanada
- Study dates
- Apr 2002to Feb 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
McMaster University
Hamilton, Ontario
Clinique Medicale L'Actuel
Montreal, Quebec
University of Ottawa Health Services
Ottawa, Ontario
Maple Leaf Clinic
Toronto, Ontario
About this study
Official title: A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients
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
- Being tested
- lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lopinavir/ritonavir; nevirapine; Zidovudine; LamivudineDrug
See Detailed Description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.
Measured: 48 weeks
Secondary outcomes (5)
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startApr 2002
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Boehringer Ingelheim, CIHR Canadian HIV Trials Network
- Responsible party
- Sponsor
- Investigators
- Julio Montaner, MD, Principal investigator, University of British Columbia/Providence Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143689
- Sponsor's protocol ID
- H02-50066
- Other IDs
- CTN 177
- Status last verified
- Sep 2014
- First submitted
- 31 Aug 2005
- Last updated
- 26 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients
- ClinicalTrials.gov ID
- NCT00143689
- Acronym / sponsor ID
- H02-50066
- Conditions
- HIV, Mitochondrial Toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Abbott, Boehringer Ingelheim, CIHR Canadian HIV Trials Network
- Study start
- Apr 2002
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lopinavir/ritonavir, Zidovudine, Lamivudine | Experimental | Drug: lopinavir/ritonavir; nevirapine; Zidovudine; LamivudineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lopinavir/ritonavir; nevirapine; Zidovudine; LamivudineSee Detailed Description. | Drug | Lopinavir/ritonavir, Zidovudine, Lamivudine |
Primary outcome
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.
Time frame: 48 weeks
5 secondary outcomes
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Montaner, MD principal investigator
University of British Columbia/Providence Health Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine in people with HIV and Mitochondrial Toxicity, run by University of British Columbia at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2014.