HIV InfectionsPhase 2NCT00225160
ALCAR Prophylaxis Study
A Phase 2 study testing acetyl L-carnitine in people with HIV Infections and Distal Symmetric Polyneuropathy, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether Acetyl L-carnitine can prevent the development of nerve damage, known as neuropathy, in individuals taking anti-HIV drugs over a 48-week period. In addition the safety and tolerability of Acetyl L-carnitine will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Distal Symmetric Polyneuropathy
- What is being tested?
- acetyl L-carnitine
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2003to not given
- Phase
- Phase 2
- 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
- Male or female, aged > 18 years of age
- HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
- Women of childbearing potential must have a negative serum (beta-HCG; performed by a medical doctor - Austria only) pregnancy test within 28 days of starting study drug (and at monthly intervals for the duration for the trial (-Austria only)
- Ability to assess level of pain and complete a pain log
- Ability to understand and provide written informed consent to participation in this trial
- All clinical laboratory values must be considered not clinically significant - for the potential response to the planned new regimen - in the opinion of the investigator
- Naïve to antiretroviral therapy
Who cannot join
- Diminished ankle reflexes (compared to the knee) or absent ankle reflexes. OR
- Distal diminution of either vibration sense in the legs (defined as perception vibration < 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) or pain or temperature sensation.
- Subjects who in the investigator's opinion are unlikely to complete the 48 weeks trial period.
- Subjects with current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subjects' ability to comply with the dosing schedule and protocol evaluations.
- Previous treatment with any drug known to induce peripheral neuropathy, specifically excessive alcohol, isoniazid \& vincristine.
- Subjects with insulin dependent diabetes or cancer and an existing peripheral neuropathy or hereditary neuropathy.
Show all 12Show fewer
- Subjects with Vitamin B 12 deficiency (level < 150pg/mL)
- Subjects using neurotoxic systemic therapeutic agents, systemic corticosteroids or immunomodulators within 30 days of randomisation.
- Use of a medication for neuropathic pain during 2 weeks prior to randomisation (including tricyclic antidepressants, mexilitene, phenytoin or carbamazepine).
- Subjects who have taken L-carnitine within 6 last months, or who have ever taken ALCAR.
- Subjects being pregnant or breast feeding.
- Subjects suffering from a serious medical condition, including one or more AIDS defining events (Appendix 8), which in the opinion of the investigator, would compromise the safety of the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double Blinded Placebo Controlled Pilot Study to Evaluate the Safety and Efficacy of Acetyl L Carnitine in Combination With Antiretroviral Therapy for the Prevention of Distal Symmetric Polyneuropathy and Lipid Abnormalities in Treatment naïve HIV Infected Subjects
The purpose of this study is to determine whether Acetyl L-carnitine can prevent the development of nerve damage, known as neuropathy, in individuals taking anti-HIV drugs over a 48-week period. In addition the safety and tolerability of Acetyl L-carnitine will be assessed.
This study compares the use of Acetyl L-carnitine or placebo (a dummy drug) in the prevention of nerve damage. The current standard of care is to use painkillers to manage the pain, with little or no effect. The possible beneficial effects of taking Acetyl L-carnitine is to prevent nerve damage as a result of anti-HIV medication.
Read more
The main purposes of the trial are:
- to look at the differences in between those on Acetyl L-carnitine versus those on placebo
- to look at the effect on state of your nervous system in the two treatment groups by measuring nerve activity
- to learn more about the safety and tolerance of Acetyl L-carnitine
- Conditions
- HIV Infections, Distal Symmetric Polyneuropathy
- Being tested
- acetyl L-carnitine
- Keywords
- HIV, poly neuropathy, acetyl L-carnitine, treatment naïve, combination antiretroviral therapy, Lipid abnormalities
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetyl L-carnitineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in total area of Protein Gene Product (PGP) immunostaining on the epidermis at 48 weeks
Secondary outcomes (13)
-Proportion of patients requiring analgesic agents
-Changes in the global assessments of pain by both subject and investigator
-Proportion of patients with HIV-1 RNA < 50 copies/ml at 24 and 48 weeks
-Proportion of patients with virological failure at 24 and 48 weeks
-Changes in CD4+ cell count from baseline after 24 and 48 weeks of treatment
-Time to discontinuation of the randomised treatment and reasons for this
-Incidence of adverse events
-Incidence of clinical disease progression
-Proportion of patients at Weeks 24 and 48 and incidence of virological and clinical failure or treatment-limiting adverse events
-Proportion of patients with changes in lipid profiles
-Change in body habitus as measured by lipodystrophy questionnaire
-Change in QOL at Weeks 24 and 48
-Changes in subcutaneous adipose tissue mtDNA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Royal Free Hampstead NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Sigma-Tau Research, Inc.
- Investigators
- Armin - Rieger, MD, Principal investigator, University of Vienna Medical School AKH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225160
- Sponsor's protocol ID
- ALCAR
- Status last verified
- Sep 2008
- First submitted
- 21 Sep 2005
- Last updated
- 18 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double Blinded Placebo Controlled Pilot Study to Evaluate the Safety and Efficacy of Acetyl L Carnitine in Combination With Antiretroviral Therapy for the Prevention of Distal Symmetric Polyneuropathy and Lipid Abnormalities in Treatment naïve HIV Infected Subjects
- ClinicalTrials.gov ID
- NCT00225160
- Acronym / sponsor ID
- ALCAR
- Conditions
- HIV Infections, Distal Symmetric Polyneuropathy
- Keywords
- HIV, poly neuropathy, acetyl L-carnitine, treatment naïve, combination antiretroviral therapy, Lipid abnormalities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Royal Free Hampstead NHS TrustUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Sigma-Tau Research, Inc.
- Study start
- Nov 2003
- First posted
- 23 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 whether Acetyl L-carnitine can prevent the development of nerve damage, known as neuropathy, in individuals taking anti-HIV drugs over a 48-week period. In addition the safety and tolerability of Acetyl L-carnitine will be assessed.
This study compares the use of Acetyl L-carnitine or placebo (a dummy drug) in the prevention of nerve damage. The current standard of care is to use painkillers to manage the pain, with little or no effect. The possible beneficial effects of taking Acetyl L-carnitine is to prevent nerve damage as a result of anti-HIV medication.
The main purposes of the trial are:
- to look at the differences in between those on Acetyl L-carnitine versus those on placebo
- to look at the effect on state of your nervous system in the two treatment groups by measuring nerve activity
- to learn more about the safety and tolerance of Acetyl L-carnitine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged > 18 years of age
- HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
- Women of childbearing potential must have a negative serum (beta-HCG; performed by a medical doctor - Austria only) pregnancy test within 28 days of starting study drug (and at monthly intervals for the duration for the trial (-Austria only)
- Ability to assess level of pain and complete a pain log
- Ability to understand and provide written informed consent to participation in this trial
Key exclusion criteria (12 listed)
- Diminished ankle reflexes (compared to the knee) or absent ankle reflexes. OR
- Distal diminution of either vibration sense in the legs (defined as perception vibration < 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) or pain or temperature sensation.
- Subjects who in the investigator's opinion are unlikely to complete the 48 weeks trial period.
- Subjects with current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subjects' ability to comply with the dosing schedule and protocol evaluations.
- Previous treatment with any drug known to induce peripheral neuropathy, specifically excessive alcohol, isoniazid \& vincristine.
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 |
|---|---|---|
| acetyl L-carnitine | Drug | – |
Primary outcome
The change from baseline in total area of Protein Gene Product (PGP) immunostaining on the epidermis at 48 weeks
13 secondary outcomes
-Proportion of patients requiring analgesic agents
-Changes in the global assessments of pain by both subject and investigator
-Proportion of patients with HIV-1 RNA < 50 copies/ml at 24 and 48 weeks
-Proportion of patients with virological failure at 24 and 48 weeks
-Changes in CD4+ cell count from baseline after 24 and 48 weeks of treatment
-Time to discontinuation of the randomised treatment and reasons for this
-Incidence of adverse events
-Incidence of clinical disease progression
-Proportion of patients at Weeks 24 and 48 and incidence of virological and clinical failure or treatment-limiting adverse events
-Proportion of patients with changes in lipid profiles
-Change in body habitus as measured by lipodystrophy questionnaire
-Change in QOL at Weeks 24 and 48
-Changes in subcutaneous adipose tissue mtDNA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2008.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingObservational study
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
HIV
RecruitingPhase 1
Dasatinib for HIV-1 Reservoir Reduction
HIV Infections
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingPhase 2
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Human Immunodeficiency Virus (HIV) Infection
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.
Armin - Rieger, MD principal investigator
University of Vienna Medical School AKH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acetyl L-carnitine in people with HIV Infections and Distal Symmetric Polyneuropathy, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 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 1 site in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The change from baseline in total area of Protein Gene Product (PGP) immunostaining on the epidermis at 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 18 Sep 2008.