HIVPhase 4TRUNCT00960622
Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects
A Phase 4 study testing Truvada, Combivir and Trizivir in people with HIV, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on Combivir or on trizivir. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Truvada, Combivir and Trizivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- infection with human immunodeficiency virus (HIV) with undetectable viral load
- on Combivir or trizivir
- able to exercise and sign consent
Who cannot join
- other active illness
- contraindication to magnetic resonance imaging (MRI) scanning or maximal exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
Official title: Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy
Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after randomization to either continuing on trizivir or combivir, or to switching to Truvada. Measurements include maximal or peak oxygen consumption, lactate production and clearance, subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction in several organ systems.
Read the detailed description
None different from the summary description above.
- Conditions
- HIV
- Being tested
- Truvada, Combivir, Trizivir
- Keywords
- treatment experienced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Also called emtricitabine and tenofovir disoproxil fumarate
Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
CombivirDrug
Also called Retrovir, zidovudine, Epivir, lamivudine
Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months
TrizivirDrug
Also called abacavir, abacavir sulfate, lamivudine, zidovudine
Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)
| Study group | Role | What they receive |
|---|---|---|
| Truvada | Experimental | Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months Receives: Drug: Truvada |
| Combivir or Trizivir | Active comparator | Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months or Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine) Receives: Drug: Combivir; Drug: Trizivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Uptake.
change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Donald P Kotler, MD, Principal investigator, St Luke's Roosevelt Hospital New York CityGabriel Ionescu, MD, Principal investigator, SLRHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960622
- Sponsor's protocol ID
- TRU
- Acronym
- TRU
- Status last verified
- Sep 2012
- First submitted
- 17 Aug 2009
- Last updated
- 4 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00960622
- Acronym / sponsor ID
- TRU / TRU
- Conditions
- HIV
- Keywords
- treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Posted 4 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after randomization to either continuing on trizivir or combivir, or to switching to Truvada. Measurements include maximal or peak oxygen consumption, lactate production and clearance, subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction in several organ systems.
Detailed description
None different from the summary description above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Truvada | Experimental | Drug: TruvadaTruvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months |
| Combivir or Trizivir | Active comparator | Drug: Combivir, Drug: TrizivirContinue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months or Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- infection with human immunodeficiency virus (HIV) with undetectable viral load
- on Combivir or trizivir
- able to exercise and sign consent
Key exclusion criteria (2 listed)
- other active illness
- contraindication to magnetic resonance imaging (MRI) scanning or maximal exercise.
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 |
|---|---|---|
| TruvadaAlso: emtricitabine and tenofovir disoproxil fumarateTruvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months | Drug | Truvada |
| CombivirAlso: Retrovir, zidovudine, Epivir, lamivudineContinue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months | Drug | Combivir or Trizivir |
| TrizivirAlso: abacavir, abacavir sulfate, lamivudine, zidovudineContinue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine) | Drug | Combivir or Trizivir |
Primary outcome
Change in Peak Oxygen Uptake.
Time frame: baseline and 6 months
change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Donald P Kotler, MD principal investigator
St Luke's Roosevelt Hospital New York City
Gabriel Ionescu, MD principal investigator
SLRHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Truvada, Combivir and Trizivir in people with HIV, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 3 inclusion and 2 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 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Peak Oxygen Uptake. (time frame: baseline and 6 months). 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 4 Mar 2013.