HIV SeronegativityPhase 1NCT00065741
Botanical/Drug Interactions in HIV: Glucuronidation
A Phase 1 study testing silymarin in people with HIV Seronegativity, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
A series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when botanicals/nutriceuticals are given concurrently via the oral route. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Seronegativity
- What is being tested?
- silymarin
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Mar 2006
- Phase
- Phase 1
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of HIV-1 infections
- Body mass index less than or equal to 30 kg/m2 and weigh at least 50 kg.
- Laboratory values obtained within 7 days of study entry within normal range for healthy volunteers.
- Able to be compliant with dosing schedules and diary record keeping.
- Able to follow dietary restrictions associated with the protocol.
- Ability and willingness to provide informed consent
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- All women of reproductive potential must have a negative pregnancy test
- All women of reproductive potential to use contraception methods as defined by protocol
- All study subjects (male and female) must agree to not participate in a conception process
Who cannot join
- History of any acute or chronic illness that requires current medical therapy including active gastrointestinal conditions that might interfere with drug absorption.
- History of hepatic, renal, cardiovascular, gastrointestinal diseases.
- Current gastrointestinal disturbance.
- Receipt of any prescribed or over the counter medication or ingested CAM during the 30 days prior to study entry except: Over the counter acetaminophen or ibuprofen at doses not exceeding package labeling guidelines.
- Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
- Pregnancy or breastfeeding.
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- Allergy/sensitivity to study agent(s) or their formulations.
- Active drug or alcohol abuse or dependence, which in the opinion of the investigator would interfere with adherence to study requirements or would endanger the subject's health while on study.
- Before entering the study, subjects must agree not to consume alcohol for 48 hours prior to PK sampling days.
- Participation in any investigational drug studies within 30 days prior to study entry and during study.
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center, Univiversity Of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
A series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and botanicals are known to rely upon or to modulate, respectively, metabolism via glucuronidation.
Read the detailed description
As per Brief Summary
- Conditions
- HIV Seronegativity
- Being tested
- silymarin
- Keywords
- Milk thistle, silymarin, piperine, glucarate, zidovudine, abacavir, mycophenolate mofetil, HIV, pharmacokinetics, interaction, glucuronidation, Healthy, Complementary Therapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silymarinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2003 (estimated)
- Study startSep 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeronegativityStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Philip C Smith, PhD, Principal investigator, School of Pharmacy, UNC Chapel HillDavid A Wohl, MD, Study director, Department of Medicine, AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065741
- Sponsor's protocol ID
- R21AT001376-01A1
- Status last verified
- Mar 2007
- First submitted
- 31 Jul 2003
- Last updated
- 23 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botanical/Drug Interactions in HIV: Glucuronidation
- ClinicalTrials.gov ID
- NCT00065741
- Acronym / sponsor ID
- R21AT001376-01A1
- Conditions
- HIV Seronegativity
- Keywords
- Milk thistle, silymarin, piperine, glucarate, zidovudine, abacavir, mycophenolate mofetil, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2003
- Study completion
- Mar 2006
- First posted
- 1 Aug 2003 (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.
A series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and botanicals are known to rely upon or to modulate, respectively, metabolism via glucuronidation.
Detailed description
As per Brief Summary
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Absence of HIV-1 infections
- Laboratory values obtained within 7 days of study entry within normal range for healthy volunteers.
- Able to be compliant with dosing schedules and diary record keeping.
- Able to follow dietary restrictions associated with the protocol.
- Ability and willingness to provide informed consent
Key exclusion criteria (10 listed)
- History of any acute or chronic illness that requires current medical therapy including active gastrointestinal conditions that might interfere with drug absorption.
- History of hepatic, renal, cardiovascular, gastrointestinal diseases.
- Current gastrointestinal disturbance.
- Receipt of any prescribed or over the counter medication or ingested CAM during the 30 days prior to study entry except: Over the counter acetaminophen or ibuprofen at doses not exceeding package labeling guidelines.
- Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
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 |
|---|---|---|
| silymarin | Drug | – |
Primary outcome
Not reported in the source record.
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 23 Mar 2007.
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.
Philip C Smith, PhD principal investigator
School of Pharmacy, UNC Chapel Hill
David A Wohl, MD study director
Department of Medicine, AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing silymarin in people with HIV Seronegativity, run by National Center for Complementary and Integrative Health (NCCIH) 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 9 inclusion and 10 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 23 Mar 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 23 Mar 2007.