HIVNCT01178684
Epidermal Nerve Fiber Density, Fat and Mitochondrial Parameters in Thai HIV+ Patients on d4T and HIV- Patients
An observational study of HIV, run by SEARCH Research Foundation at 1 site in Thailand.
Trial summary
This study will provide the range of Epidermal Nerve Fiber Density (ENFD) typically seen in Thai individuals. ENFD values from Thai HIV-negative subjects without neuropathy will be used as appropriate reference norm for Thai HIV-positive subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 113 participants
- Where
- 1 siteThailand
- Study dates
- May 2010to Dec 2012
- Phase
- Observational
- 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
Study population: Seventy five HIV-positive patients on long-term d4T treatment (25 with symptomatic peripheral neuropathy, 25 without peripheral neuropathy and 25 with asymptomatic peripheral neuropathy) and 50 HIV-negative subjects without peripheral neuropathy will be recruited from the Thai Red Cross AIDS Research Centre and the Queen Savang Vadhana Memorial Hospital.
Who may be able to join
- Documented HIV-1 infection
- Age ≥ 18 years old
- Has Thai national identification card
- Subject on d4T treatment with symptoms of neuropathy which developed after start of d4T therapy
- Evidence of symptomatic persistent symptoms of pain, tingling or numbness of lower extremities AND bilateral lower extremity neuropathy on exam at entry.
- Subject understands the study and is able to sign informed consent
- HIV RNA by PCR < 50 copies/mL
Who cannot join
- Treatment with concomitant medications (other than d4T) or having conditions (e.g. compressive neuropathy, diabetes, vitamin B12 deficiency, excessive alcohol intake meeting substance dependence criteria by DSM-IV, hepatitis C infection) known to cause neuropathy
- History of allergy to any anesthetic medications
- Pregnancy
- Group 2 subjects will meet the same criteria described above for group 1 subjects, but will NOT have symptoms OR signs of neuropathy.
- Group 3 subjects will meet the same criteria described above for group 1 subjects, but will NOT have symptoms OR signs of neuropathy and will have documented
- Group 4 subjects will meet the same criteria described above for group 1 subject, but will have evidence of symptomatic persistent symptoms of pain, tingling or numbness of lower extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Epidermal Nerve Fiber Density, Subcutaneous Fat, and Mitochondrial Parameters in Thai HIV-positive Patients on Long-term Stavudine Treatment and in Thai HIV-negative Patients
This study will provide the range of Epidermal Nerve Fiber Density (ENFD) typically seen in Thai individuals. ENFD values from Thai HIV-negative subjects without neuropathy will be used as appropriate reference norm for Thai HIV-positive subjects. In particular, comparison of ENFD values from Thai HIV-negative subjects with baseline ENFD values in Thai HIV-positive subjects prior to highly active antiretroviral therapy (HAART) will allow examination of the effect of HIV per se on ENFD. ENFD from Thai HIV-positive subjects on long-term d4T (stavudine) with and without neuropathy will also provide reference ENFD values at the extremes of the disease process i.e. extent of ENFD decrease in subjects with d4T-induced symptomatic neuropathy and in subjects completely free of disease despite d4T treatment for comparison with Thai HIV-positive subjects on short-term d4T in SEARCH 003 study.
Read the detailed description
The range of changes in epidermal nerve fiber density (ENFD), subcutaneous fat, and mitochondrial function induced by stavudine (d4T)-based therapy is currently not known, globally or specifically in the Thai population. This study will evaluate ENFD and subcutaneous fat and peripheral blood mitochondrial parameters in 4 groups of subjects. Group 1 will include Thai HIV-positive subjects on long-term d4T treatment with symptomatic peripheral neuropathy. Group 2 will include Thai HIV-positive subjects on long-term d4T treatment without peripheral neuropathy. Group 3 will include HIV-negative subjects without peripheral neuropathy.Group 4 will include Thai HIV-positive subjects on long-term d4T treatment with asymptomatic peripheral neuropathy. Information gained from Thai HIV-positive subjects on long-term d4T treatment with and without neuropathy in this study will provide range of positive control values for subjects in the SEARCH 003 study and other studies looking at the influence of antiretroviral agents on peripheral nerve, fat, and mitochondria. Information gained from Thai HIV-negative subjects without neuropathy can be used as negative control values for subjects in the SEARCH 003 study and other studies looking at the influence of HIV or other diseases/pathogens on peripheral nerve, fat, and mitochondria.
Hypothesis
- HIV-positive patients who have been on long-term d4T treatment with symptomatic peripheral neuropathy will have less ENFD, increased lipoatrophy, and altered mitochondrial function than those on long-term d4T treatment with asymptomatic peripheral neuropathy and those on long-term d4T treatment without peripheral neuropathy.
- HIV-negative patients without peripheral neuropathy will have more ENFD, no lipoatrophy, and better mitochondrial function than HIV-positive patients.
The SEARCH 003 study will assess the extent of deterioration in ENFD induced by short-term (from entry to 24 weeks) d4T use and the degree of improvement following discontinuation of d4T (from week 24 to 72). However the range of changes in ENFD and in other mitochondrial parameters induced by d4T-based therapy in not known, globally or specifically in the Thai population.
This is a cross-sectional study that will enroll 25 HIV-positive subjects on long-term d4T treatment with symptomatic peripheral neuropathy, 25 HIV-positive subjects on long-term d4T treatment without peripheral neuropathy, 50 HIV-negative subjects without peripheral neuropathy and 25 HIV-positive subjects on long-term d4T treatment with asymptomatic peripheral neuropathy for a one-time assessment.
- Conditions
- HIV
- Keywords
- ENFD, epidermal nerve fiber density, HIV, HIV-infection
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1: HIV-pos on d4T with neuropathy | Not described | |
| 2: HIV-pos on d4T without neuropathy | Not described | |
| 3: HIV-neg without peripheral neuropathy | Not described | |
| 4 HIV-pos on d4T with asymtomatic neuropathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of nerves in the skin
To compare differences in ENFD between the 4 groups
- group 1: HIV-positive subjects on long-term d4T with symptomatic peripheral neuropathy
- group 2: HIV-positive subjects on long-term d4T without peripheral neuropathy
- group 3: HIV-negative subjects without peripheral neuropathy
- group 4: HIV-positive subjects on long-term d4T with asymptomatic peripheral neuropathy
Measured: Baseline
Condition of lipoatrophy
To compare differences lipoatrophy between the 4 groups
- group 1: HIV-positive subjects on long-term d4T with symptomatic peripheral neuropathy
- group 2: HIV-positive subjects on long-term d4T without peripheral neuropathy
- group 3: HIV-negative subjects without peripheral neuropathy
- group 4: HIV-positive subjects on long-term d4T with asymptomatic peripheral neuropathy
Measured: Baseline
Secondary outcomes (3)
Mitochondrial parameters
Measured: Baseline
Intracellular concentrations of d4T triphosphate
Measured: Baseline
HIV DNA in peripheral blood mononuclear cell (PBMC)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2012
- Study completionDec 2012
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.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEARCH Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii
- Responsible party
- Principal investigator, Assoc.Prof.Jintanat Ananworanich, M.D., SEARCH Research Foundation
- Investigators
- Jintanat Ananworanich, MD, PhD, Principal investigator, SEARCH Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178684
- Sponsor's protocol ID
- SEARCH 014
- Status last verified
- Sep 2014
- First submitted
- 11 Jun 2010
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- 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
- Study of Epidermal Nerve Fiber Density, Subcutaneous Fat, and Mitochondrial Parameters in Thai HIV-positive Patients on Long-term Stavudine Treatment and in Thai HIV-negative Patients
- ClinicalTrials.gov ID
- NCT01178684
- Acronym / sponsor ID
- SEARCH 014
- Conditions
- HIV
- Keywords
- ENFD, epidermal nerve fiber density, HIV, HIV-infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- SEARCH Research FoundationUniversity, hospital or other
- Collaborators
- University of Hawaii
- Study start
- May 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Aug 2010 (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 provide the range of Epidermal Nerve Fiber Density (ENFD) typically seen in Thai individuals. ENFD values from Thai HIV-negative subjects without neuropathy will be used as appropriate reference norm for Thai HIV-positive subjects. In particular, comparison of ENFD values from Thai HIV-negative subjects with baseline ENFD values in Thai HIV-positive subjects prior to highly active antiretroviral therapy (HAART) will allow examination of the effect of HIV per se on ENFD. ENFD from Thai HIV-positive subjects on long-term d4T (stavudine) with and without neuropathy will also provide reference ENFD values at the extremes of the disease process i.e. extent of ENFD decrease in subjects with d4T-induced symptomatic neuropathy and in subjects completely free of disease despite d4T treatment for comparison with Thai HIV-positive subjects on short-term d4T in SEARCH 003 study.
Detailed description
The range of changes in epidermal nerve fiber density (ENFD), subcutaneous fat, and mitochondrial function induced by stavudine (d4T)-based therapy is currently not known, globally or specifically in the Thai population. This study will evaluate ENFD and subcutaneous fat and peripheral blood mitochondrial parameters in 4 groups of subjects. Group 1 will include Thai HIV-positive subjects on long-term d4T treatment with symptomatic peripheral neuropathy. Group 2 will include Thai HIV-positive subjects on long-term d4T treatment without peripheral neuropathy. Group 3 will include HIV-negative subjects without peripheral neuropathy.Group 4 will include Thai HIV-positive subjects on long-term d4T treatment with asymptomatic peripheral neuropathy. Information gained from Thai HIV-positive subjects on long-term d4T treatment with and without neuropathy in this study will provide range of positive control values for subjects in the SEARCH 003 study and other studies looking at the influence of antiretroviral agents on peripheral nerve, fat, and mitochondria. Information gained from Thai HIV-negative subjects without neuropathy can be used as negative control values for subjects in the SEARCH 003 study and other studies looking at the influence of HIV or other diseases/pathogens on peripheral nerve, fat, and mitochondria.
Hypothesis
- HIV-positive patients who have been on long-term d4T treatment with symptomatic peripheral neuropathy will have less ENFD, increased lipoatrophy, and altered mitochondrial function than those on long-term d4T treatment with asymptomatic peripheral neuropathy and those on long-term d4T treatment without peripheral neuropathy.
- HIV-negative patients without peripheral neuropathy will have more ENFD, no lipoatrophy, and better mitochondrial function than HIV-positive patients.
The SEARCH 003 study will assess the extent of deterioration in ENFD induced by short-term (from entry to 24 weeks) d4T use and the degree of improvement following discontinuation of d4T (from week 24 to 72). However the range of changes in ENFD and in other mitochondrial parameters induced by d4T-based therapy in not known, globally or specifically in the Thai population.
This is a cross-sectional study that will enroll 25 HIV-positive subjects on long-term d4T treatment with symptomatic peripheral neuropathy, 25 HIV-positive subjects on long-term d4T treatment without peripheral neuropathy, 50 HIV-negative subjects without peripheral neuropathy and 25 HIV-positive subjects on long-term d4T treatment with asymptomatic peripheral neuropathy for a one-time assessment.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: HIV-pos on d4T with neuropathy | – | – |
| 2: HIV-pos on d4T without neuropathy | – | – |
| 3: HIV-neg without peripheral neuropathy | – | – |
| 4 HIV-pos on d4T with asymtomatic neuropathy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Seventy five HIV-positive patients on long-term d4T treatment (25 with symptomatic peripheral neuropathy, 25 without peripheral neuropathy and 25 with asymptomatic peripheral neuropathy) and 50 HIV-negative subjects without peripheral neuropathy will be recruited from the Thai Red Cross AIDS Research Centre and the Queen Savang Vadhana Memorial Hospital.
Key inclusion criteria (7 listed)
- Documented HIV-1 infection
- Age ≥ 18 years old
- Has Thai national identification card
- Subject on d4T treatment with symptoms of neuropathy which developed after start of d4T therapy
- Evidence of symptomatic persistent symptoms of pain, tingling or numbness of lower extremities AND bilateral lower extremity neuropathy on exam at entry.
Key exclusion criteria (6 listed)
- Treatment with concomitant medications (other than d4T) or having conditions (e.g. compressive neuropathy, diabetes, vitamin B12 deficiency, excessive alcohol intake meeting substance dependence criteria by DSM-IV, hepatitis C infection) known to cause neuropathy
- History of allergy to any anesthetic medications
- Pregnancy
- Group 2 subjects will meet the same criteria described above for group 1 subjects, but will NOT have symptoms OR signs of neuropathy.
- Group 3 subjects will meet the same criteria described above for group 1 subjects, but will NOT have symptoms OR signs of neuropathy and will have documented
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of nerves in the skin
Time frame: Baseline
To compare differences in ENFD between the 4 groups * group 1: HIV-positive subjects on long-term d4T with symptomatic peripheral neuropathy * group 2: HIV-positive subjects on long-term d4T without peripheral neuropathy * group 3: HIV-negative subjects without peripheral neuropathy * group 4: HIV-positive subjects on long-term d4T with asymptomatic peripheral neuropathy
Condition of lipoatrophy
Time frame: Baseline
To compare differences lipoatrophy between the 4 groups * group 1: HIV-positive subjects on long-term d4T with symptomatic peripheral neuropathy * group 2: HIV-positive subjects on long-term d4T without peripheral neuropathy * group 3: HIV-negative subjects without peripheral neuropathy * group 4: HIV-positive subjects on long-term d4T with asymptomatic peripheral neuropathy
3 secondary outcomes
Mitochondrial parameters
Time frame: Baseline
Intracellular concentrations of d4T triphosphate
Time frame: Baseline
HIV DNA in peripheral blood mononuclear cell (PBMC)
Time frame: Baseline
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.
Jintanat Ananworanich, MD, PhD principal investigator
SEARCH Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by SEARCH Research Foundation at 1 site in Thailand.
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 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 1 site in Thailand. 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.
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?
Number of nerves in the skin (time frame: Baseline). The study lists 2 primary outcomes in all. 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.