Acidosis, LacticPhase 2/3NCT00143702
D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)
A Phase 2/3 study testing d4T, Abacavir and Riboflavin and Thiamine (Supplementation) in people with Acidosis, Lactic, run by University of British Columbia at 2 sites in Canada.
Trial summary
The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acidosis, Lactic
- What is being tested?
- d4T, Abacavir and Riboflavin and Thiamine (Supplementation)
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2001to Aug 2006
- Phase
- Phase 2/3
- 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 18 years of age or older
- Have a viral load equal to or below 50 copies/mL
- Have been on a d4T-containing multiple drug regimen (at least three agents in total) for at least six months
- Have been on a stable ARV regimen for the three months prior to enrollment
- Have a venous lactic acid measurement above 2.1 mmol/L within the three months prior to enrollment and two consecutive measurements above 2.1 but lower than 6.0 within a two-week period of screening
- Be willing to discontinue L-carnitine and/or coenzyme Q10
- Be willing and able to provide informed consent
Who cannot join
- Pregnancy or breastfeeding
- Venous lactic acid equal to or above 6.0 mmol/L
- Previous exposure to abacavir
- Virologic rebound while on a previous regimen consisting of dual or triple nucleoside reverse transcriptase inhibitors (NRTIs)
- Use of hydroxyurea within the three months prior to enrollment
- Use of metformin
Show all 9Show fewer
- Any acute cardiopulmonary illness or infection
- New AIDS-defining illness diagnosed within four weeks of enrollment
- Riboflavin or thiamine supplementation above 20 mg/day within 30 days prior to enrollment
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Positive Care Clinic
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Randomized, Open-Label Study of Continued Stavudine Versus Abacavir Substitution With or Without Riboflavin and Thiamine Supplementation in HIV-Infected Patients Who Have Elevated Venous Lactic Acid While on Stavudine-Based Therapy (DAVE)
The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed.
Participants will be randomly assigned to one of four groups:
Read more
- Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements
- Group 2 will continue to take d4T without vitamin supplements
- Group 3 will switch from d4T to abacavir and receive the vitamins
- Group 4 will switch from d4T to abacavir without vitamin supplements.
The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
- Conditions
- Acidosis, Lactic
- Being tested
- d4T, Abacavir, Riboflavin and Thiamine (Supplementation)
- Keywords
- Elevated Lactic Acid
- Medical subject headings
- Acidosis, Lactic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d4TDrug
See Detailed Description.
AbacavirDrug
See Detailed Description.
Riboflavin and Thiamine (Supplementation)Drug
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients per arm with random venous lactic acid (RVLA) below or equal to 2.1 mmol/L* at 16 weeks. (* Confirmed by a second determination 7-14 days later.)
Measured: 16 weeks
Secondary outcomes (10)
Rate of decline of RVLA levels
Absolute level of change of RVLA levels using baseline values as a covariant
Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern
Time to event: time to normalize venous lactic acid
Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death
Proportion of patients with at least three consecutive HIV-1 RNA determinations equal to or below 50 copies/mL during the 16 week follow-up period on an intention to treat basis
Measured: 16 weeks
Change in absolute CD4 from baseline
Absolute CD4/CD8 counts
Incidence of grade III and greater adverse drug effects
Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology)
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 startAug 2001
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acidosis, LacticStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, CIHR Canadian HIV Trials Network
- Investigators
- Julio Montaner, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143702
- Sponsor's protocol ID
- P00-0159
- Other IDs
- CTN 169
- Status last verified
- Sep 2005
- First submitted
- 31 Aug 2005
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label Study of Continued Stavudine Versus Abacavir Substitution With or Without Riboflavin and Thiamine Supplementation in HIV-Infected Patients Who Have Elevated Venous Lactic Acid While on Stavudine-Based Therapy (DAVE)
- ClinicalTrials.gov ID
- NCT00143702
- Acronym / sponsor ID
- P00-0159
- Conditions
- Acidosis, Lactic
- Keywords
- Elevated Lactic Acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, CIHR Canadian HIV Trials Network
- Study start
- Aug 2001
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (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.
The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed.
Participants will be randomly assigned to one of four groups:
- Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements
- Group 2 will continue to take d4T without vitamin supplements
- Group 3 will switch from d4T to abacavir and receive the vitamins
- Group 4 will switch from d4T to abacavir without vitamin supplements.
The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be HIV-positive
- Be 18 years of age or older
- Have a viral load equal to or below 50 copies/mL
- Have been on a d4T-containing multiple drug regimen (at least three agents in total) for at least six months
- Have been on a stable ARV regimen for the three months prior to enrollment
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding
- Venous lactic acid equal to or above 6.0 mmol/L
- Previous exposure to abacavir
- Virologic rebound while on a previous regimen consisting of dual or triple nucleoside reverse transcriptase inhibitors (NRTIs)
- Use of hydroxyurea within the three months prior to enrollment
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 |
|---|---|---|
| d4TSee Detailed Description. | Drug | – |
| AbacavirSee Detailed Description. | Drug | – |
| Riboflavin and Thiamine (Supplementation)See Detailed Description. | Drug | – |
Primary outcome
Proportion of patients per arm with random venous lactic acid (RVLA) below or equal to 2.1 mmol/L* at 16 weeks. (* Confirmed by a second determination 7-14 days later.)
Time frame: 16 weeks
10 secondary outcomes
Rate of decline of RVLA levels
Absolute level of change of RVLA levels using baseline values as a covariant
Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern
Time to event: time to normalize venous lactic acid
Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death
Proportion of patients with at least three consecutive HIV-1 RNA determinations equal to or below 50 copies/mL during the 16 week follow-up period on an intention to treat basis
Time frame: 16 weeks
Change in absolute CD4 from baseline
Absolute CD4/CD8 counts
Incidence of grade III and greater adverse drug effects
Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology)
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 25 Sep 2008.
Related trials for Acidosis, Lactic
RecruitingPhase 3
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
Not yet recruitingPhase 1/2
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)
RecruitingObservational study
North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC)
Mitochondrial Disorders, Mitochondrial Genetic Disorders
RecruitingObservational study
Lactic Acidosis and Prior Metformin Treatment
Type 2 Diabetes
RecruitingObservational study
Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning
Drug Overdose, Metformin
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing d4T, Abacavir and Riboflavin and Thiamine (Supplementation) in people with Acidosis, Lactic, run by University of British Columbia at 2 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 8 inclusion and 9 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 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of patients per arm with random venous lactic acid (RVLA) below or equal to 2.1 mmol/L* at 16 weeks. (* Confirmed by a second determination 7-14 days later.) (time frame: 16 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 25 Sep 2008.