Examining Hair to Determine Tenofovir Exposure

NCT00903084 | Completed Phase 1

• 2 other identifiers: R21MH085598DAHBR 9A-ASPQ
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV

Keywords

Pharmacokinetics in Hair; Tenofovir; Pharmacokinetics; Concentrations; Hair

Outcome Measures

Primary Outcomes (1)

• Tenofovir hair concentration under each dosing condition

  Measured 6 weeks after starting each dosing condition

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: Tenofovir Disoproxil Fumarate

Interventions

Tenofovir Disoproxil Fumarate DRUG

300-mg tablet

Also known as: Viread, Tenofovir

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

University of California, San Francisco

San Francisco, California, 94122, United States

Location

Related Publications (5)

• 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.

  PMID: 19165084 BACKGROUND

• Huang 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.

  PMID: 18837069 BACKGROUND

• Gandhi 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.

  PMID: 12379072 BACKGROUND

• Liu 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.

  PMID: 24421901 RESULT

• Anderson 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.

  PMID: 22972843 RESULT

Related Links

• Click here for the San Francisco Department of Public Health HIV Research Section

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Albert Liu, MD, MPH

  San Francisco Department of Public Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, HIV Prevention Intervention Studies SFDPH/Bridge HIV

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

US (2)