HIVPhase 1NCT00903084
Examining Hair to Determine Tenofovir Exposure
A Phase 1 study testing Tenofovir Disoproxil Fumarate in people with HIV, run by Public Health Foundation Enterprises, Inc. at 2 sites in United States.
Trial summary
This study will determine whether a hair test can reveal how much of the anti-HIV medication tenofovir a person without HIV has been exposed to. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Tenofovir Disoproxil Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Jun 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to speak English
- HIV-1 uninfected, based on HIV rapid testing performed during screening and enrollment
- Calculated creatinine clearance greater than or equal to 60 mL/min by the Cockcroft-Gault creatinine clearance formula
- Serum creatinine less than or equal to the site laboratory upper limit of normal
- Urine dipstick with negative or trace result for both glucose and protein
- Negative urine beta human chorionic gonadotropin (beta-HCG) test for women
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- Adequate hepatic function, defined as total bilirubin and hepatic transaminases (ALT and AST) less than or equal to twice the upper limit of normal
- Adequate hematologic function, defined as an absolute neutrophil count greater than or equal to 1,500/mm3, platelet count greater than or equal to 100,000/mm3, and hemoglobin greater than or equal to 10 g/dL
- Ability to participate in modified directly observed dosing of study drug
- Ability to provide a personal cell phone number to be contacted on for unobserved modified directly observed therapy (mDOT) visits
- Minimum length of 3 cm scalp hair in occipital region
- Willing to provide hair and plasma samples as specified by the protocol
- Dark hair (brown or black), as assessed by the study clinician
- Volunteers born female must agree to consistently use effective contraception from at least 21 days prior to enrollment through the last protocol visit for sexual activity that could lead to pregnancy and agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last scheduled protocol visit.
Who cannot join
- Active and serious medical problems, including heart or lung disease, diabetes requiring hypoglycemia medications, previously diagnosed malignancies expected to require further treatment, and serious infections
- Hepatitis B surface antigen positivity
- History of chronic kidney disease
- Known osteoporosis, osteomalacia, or osteopenia
- History of pathological bone fractures not related to trauma
- Receiving ongoing therapy with any of the following: antiretroviral therapy, interferon or interleukin therapy, aminoglycoside antibiotics, amphotericin B, cidofovir, systemic chemotherapeutic agents, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), or other investigational agents
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- Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting that may confer an inability to receive an orally administered medication
- Use of hair dyes or hair permanent products in the last 3 months (streaking is acceptable)
- Current participation in any other research study involving drugs, investigational agents, or medical devices
- Breastfeeding at screening or enrollment, per participant report
- Active alcohol or drug use considered sufficient by clinician to hinder compliance with study procedures
- Elevated risk of HIV infection, as defined in the study protocol
- At enrollment, has any social or medical condition that, in the investigator's opinion, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco Department of Public Health
San Francisco, California, 94102
University of California, San Francisco
San Francisco, California, 94122
About this study
Official title: A Phase 1 Pharmacokinetic Study of Varying Dosing Patterns on Tenofovir Concentrations in Hair
This study will determine whether a hair test can reveal how much of the anti-HIV medication tenofovir a person without HIV has been exposed to.
Read the detailed description
Pre-exposure prophylaxis (PrEP) is a new strategy for the prevention of HIV infection. It involves providing antiretroviral medications-those that treat HIV infections-to people before they are exposed to HIV. In clinical trials of PrEP, several of which are currently under way, accurate measurements are needed of how much exposure participants have to the PrEP medications. Current methods, such as self-reports of medication adherence or pill counting, can lead to inaccurate readings of PrEP exposure because participants may forget to take pills and individual differences may affect levels of exposure. Measuring PrEP exposure levels in hair yields an objective marker of exposure that is not subject to self-report errors and that takes into account individual differences. This study will test the use of a hair sample for assessing the level of exposure to tenofovir disoproxil fumarate (TDF), an antiretroviral medication, in people not infected with HIV.
Participation in this study will last 9 months. Participants will undergo baseline testing and then will be randomly assigned to begin one of three conditions, based on dosing schedule: receiving TDF 2, 4, or 7 days per week. All participants will complete each of these dosing schedules, but the order in which they are completed will be randomly assigned. Each dosing schedule will last 6 weeks, with a break of several weeks between them. During each dosing schedule, study staff will confirm that participants are taking each scheduled dose by watching them take the pills on weekdays and calling them on weekends. Follow-up visits will occur at Days 1, 21, and 42 of each dosing schedule. During the baseline and follow-up visits, the following will be completed: an HIV rapid test; counseling about HIV prevention; a brief physical exam; a talk with a staff member about health, symptoms, and other medications; a blood draw, which will be used for several tests; collection of a urine sample and pregnancy test; and optional donation of a sample of pubic hair. On the last day of each dosing schedule, a small sample of hair will be cut from each participant's scalp. An additional follow-up visit will occur after participants complete 4 weeks of the 7-day dosing schedule. This visit will last 24 hours and will involve collection of additional blood samples.
- Conditions
- HIV
- Being tested
- Tenofovir Disoproxil Fumarate
- Keywords
- Pharmacokinetics in Hair, Tenofovir, Pharmacokinetics, Concentrations, Hair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
Also called Viread, Tenofovir
300-mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive 7 doses per week, then 4 doses per week, then 2 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. Receives: Drug: Tenofovir Disoproxil Fumarate |
| 2 | Active comparator | Participants will receive 7 doses per week, then 2 doses per week, then 4 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. Receives: Drug: Tenofovir Disoproxil Fumarate |
| 3 | Active comparator | Participants will receive 4 doses per week, then 7 doses per week, then 2 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. Receives: Drug: Tenofovir Disoproxil Fumarate |
| 4 | Active comparator | Participants will receive 4 doses per week, then 2 doses per week, then 7 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. Receives: Drug: Tenofovir Disoproxil Fumarate |
| 5 | Active comparator | Participants will receive 2 doses per week, then 7 doses per week, then 4 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. Receives: Drug: Tenofovir Disoproxil Fumarate |
| 6 | Active comparator | Participants will receive 2 doses per week, then 4 doses per week, then 7 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. Receives: Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tenofovir hair concentration under each dosing condition
Measured: Measured 6 weeks after starting each dosing condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Albert Liu, Public Health Foundation Enterprises, Inc.
- Investigators
- Albert Liu, MD, MPH, Study chair, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903084
- Sponsor's protocol ID
- R21MH085598
- Other IDs
- R21MH085598, DAHBR 9A-ASPQ
- Status last verified
- Apr 2015
- First submitted
- 13 May 2009
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gandhi M, Ameli N, Bacchetti P, Gange SJ, Anastos K, Levine A, Hyman CL, Cohen M, Young M, Huang Y, Greenblatt RM; Women's Interagency HIV Study (WIHS). Protease inhibitor levels in hair strongly predict virologic response to treatment. AIDS. 2009 Feb 20;23(4):471-8. doi: 10.1097/QAD.0b013e328325a4a9.
PubMed 19165084Huang Y, Gandhi M, Greenblatt RM, Gee W, Lin ET, Messenkoff N. Sensitive analysis of anti-HIV drugs, efavirenz, lopinavir and ritonavir, in human hair by liquid chromatography coupled with tandem mass spectrometry. Rapid Commun Mass Spectrom. 2008 Nov;22(21):3401-9. doi: 10.1002/rcm.3750.
PubMed 18837069Gandhi M, Greenblatt RM. Hair it is: the long and short of monitoring antiretroviral treatment. Ann Intern Med. 2002 Oct 15;137(8):696-7. doi: 10.7326/0003-4819-137-8-200210150-00016. No abstract available.
PubMed 12379072Liu AY, Yang Q, Huang Y, Bacchetti P, Anderson PL, Jin C, Goggin K, Stojanovski K, Grant R, Buchbinder SP, Greenblatt RM, Gandhi M. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP). PLoS One. 2014 Jan 8;9(1):e83736. doi: 10.1371/journal.pone.0083736. eCollection 2014.
PubMed 24421901Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, McMahan V, Bushman LR, Casapia M, Montoya-Herrera O, Veloso VG, Mayer KH, Chariyalertsak S, Schechter M, Bekker LG, Kallas EG, Grant RM; iPrEx Study Team. Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men. Sci Transl Med. 2012 Sep 12;4(151):151ra125. doi: 10.1126/scitranslmed.3004006.
PubMed 22972843
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetic Study of Varying Dosing Patterns on Tenofovir Concentrations in Hair
- ClinicalTrials.gov ID
- NCT00903084
- Acronym / sponsor ID
- R21MH085598
- Conditions
- HIV
- Keywords
- Pharmacokinetics in Hair, Tenofovir, Pharmacokinetics, Concentrations, Hair
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 May 2009 (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 determine whether a hair test can reveal how much of the anti-HIV medication tenofovir a person without HIV has been exposed to.
Detailed description
Pre-exposure prophylaxis (PrEP) is a new strategy for the prevention of HIV infection. It involves providing antiretroviral medications-those that treat HIV infections-to people before they are exposed to HIV. In clinical trials of PrEP, several of which are currently under way, accurate measurements are needed of how much exposure participants have to the PrEP medications. Current methods, such as self-reports of medication adherence or pill counting, can lead to inaccurate readings of PrEP exposure because participants may forget to take pills and individual differences may affect levels of exposure. Measuring PrEP exposure levels in hair yields an objective marker of exposure that is not subject to self-report errors and that takes into account individual differences. This study will test the use of a hair sample for assessing the level of exposure to tenofovir disoproxil fumarate (TDF), an antiretroviral medication, in people not infected with HIV.
Participation in this study will last 9 months. Participants will undergo baseline testing and then will be randomly assigned to begin one of three conditions, based on dosing schedule: receiving TDF 2, 4, or 7 days per week. All participants will complete each of these dosing schedules, but the order in which they are completed will be randomly assigned. Each dosing schedule will last 6 weeks, with a break of several weeks between them. During each dosing schedule, study staff will confirm that participants are taking each scheduled dose by watching them take the pills on weekdays and calling them on weekends. Follow-up visits will occur at Days 1, 21, and 42 of each dosing schedule. During the baseline and follow-up visits, the following will be completed: an HIV rapid test; counseling about HIV prevention; a brief physical exam; a talk with a staff member about health, symptoms, and other medications; a blood draw, which will be used for several tests; collection of a urine sample and pregnancy test; and optional donation of a sample of pubic hair. On the last day of each dosing schedule, a small sample of hair will be cut from each participant's scalp. An additional follow-up visit will occur after participants complete 4 weeks of the 7-day dosing schedule. This visit will last 24 hours and will involve collection of additional blood samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tenofovir Disoproxil FumarateParticipants will receive 7 doses per week, then 4 doses per week, then 2 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. |
| 2 | Active comparator | Drug: Tenofovir Disoproxil FumarateParticipants will receive 7 doses per week, then 2 doses per week, then 4 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. |
| 3 | Active comparator | Drug: Tenofovir Disoproxil FumarateParticipants will receive 4 doses per week, then 7 doses per week, then 2 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. |
| 4 | Active comparator | Drug: Tenofovir Disoproxil FumarateParticipants will receive 4 doses per week, then 2 doses per week, then 7 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. |
| 5 | Active comparator | Drug: Tenofovir Disoproxil FumarateParticipants will receive 2 doses per week, then 7 doses per week, then 4 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. |
| 6 | Active comparator | Drug: Tenofovir Disoproxil FumarateParticipants will receive 2 doses per week, then 4 doses per week, then 7 doses per week (each for 6 weeks) of tenofovir, with a break in between dosing periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to speak English
- HIV-1 uninfected, based on HIV rapid testing performed during screening and enrollment
- Calculated creatinine clearance greater than or equal to 60 mL/min by the Cockcroft-Gault creatinine clearance formula
- Serum creatinine less than or equal to the site laboratory upper limit of normal
- Urine dipstick with negative or trace result for both glucose and protein
Key exclusion criteria (13 listed)
- Active and serious medical problems, including heart or lung disease, diabetes requiring hypoglycemia medications, previously diagnosed malignancies expected to require further treatment, and serious infections
- Hepatitis B surface antigen positivity
- History of chronic kidney disease
- Known osteoporosis, osteomalacia, or osteopenia
- History of pathological bone fractures not related to trauma
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 |
|---|---|---|
| Tenofovir Disoproxil FumarateAlso: Viread, Tenofovir300-mg tablet | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Tenofovir hair concentration under each dosing condition
Time frame: Measured 6 weeks after starting each dosing condition
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 6 Apr 2015.
- Background: PubMed 19165084Gandhi M, Ameli N, Bacchetti P, Gange SJ, Anastos K, Levine A, Hyman CL, Cohen M, Young M, Huang Y, Greenblatt RM; Women's Interagency HIV Study (WIHS). Protease inhibitor levels in hair strongly predict virologic response to treatment. AIDS. 2009 Feb 20;23(4):471-8. doi: 10.1097/QAD.0b013e328325a4a9.
- Background: PubMed 18837069Huang Y, Gandhi M, Greenblatt RM, Gee W, Lin ET, Messenkoff N. Sensitive analysis of anti-HIV drugs, efavirenz, lopinavir and ritonavir, in human hair by liquid chromatography coupled with tandem mass spectrometry. Rapid Commun Mass Spectrom. 2008 Nov;22(21):3401-9. doi: 10.1002/rcm.3750.
- Background: PubMed 12379072Gandhi M, Greenblatt RM. Hair it is: the long and short of monitoring antiretroviral treatment. Ann Intern Med. 2002 Oct 15;137(8):696-7. doi: 10.7326/0003-4819-137-8-200210150-00016. No abstract available.
- Results publication: PubMed 24421901Liu AY, Yang Q, Huang Y, Bacchetti P, Anderson PL, Jin C, Goggin K, Stojanovski K, Grant R, Buchbinder SP, Greenblatt RM, Gandhi M. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP). PLoS One. 2014 Jan 8;9(1):e83736. doi: 10.1371/journal.pone.0083736. eCollection 2014.
- Results publication: PubMed 22972843Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, McMahan V, Bushman LR, Casapia M, Montoya-Herrera O, Veloso VG, Mayer KH, Chariyalertsak S, Schechter M, Bekker LG, Kallas EG, Grant RM; iPrEx Study Team. Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men. Sci Transl Med. 2012 Sep 12;4(151):151ra125. doi: 10.1126/scitranslmed.3004006.
- Click here for the San Francisco Department of Public Health HIV Research SectionLink provided by the sponsor.
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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.
Albert Liu, MD, MPH study chair
San Francisco Department of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir Disoproxil Fumarate in people with HIV, run by Public Health Foundation Enterprises, Inc. at 2 sites 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 14 inclusion and 13 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 6 Apr 2015. 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 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.
What does the primary outcome measure?
Tenofovir hair concentration under each dosing condition (time frame: Measured 6 weeks after starting each dosing condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00903084, which also lists 5 linked publications.
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 6 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.