NRTI-Sparing Pilot Study (NCT00143689) | Clinical Trial Compass
CompletedPhase 4
NRTI-Sparing Pilot Study
Canada13 participantsStarted 2002-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.