Single Dose Truvada in HIV-negative Men and Women

NCT01326221 | Completed

• 1 other identifier: 08-0410
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and emtricitabine (components of Truvada) concentrations within genital tract of male and females after a single dose of Truvada®. Concentrations of the active drug will be measured in blood (women and men), cervicovaginal aspirates and vaginal tissue (women only), seminal fluid and rectal tissue (men only). Samples will be obtained at 24 hours (1 day), 48 hours (2 days), 5 days, 7 days, 10 days, and 14 days post-dose. Each subject will undergo 2 biopsy days, at least 72 hours apart. Additionally, tissue samples will be evaluated ex-vivo for HIV infectivity.

Conditions

Pharmacokinetic Study in Healthy Volunteers

Keywords

Truvada; tenofovir; emtricitabine; Pharmacokinetics; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• TFV, TFV-DP, FTC, FTC-TP in blood, CVF, cervical and vaginal and rectal tissue over 14 days

  The study aims to examine intra- and extracellular tenofovir and emtricitabine concentrations in various human compartments after a single dose, and to look at the potential for HIV infectivity in tissue samples from these compartments.

  14 days

Study Arms (1)

1

Single dose of Truvada

Drug: tenofovir + emtricitabine

Interventions

tenofovir + emtricitabine DRUG

tenofovir 300mg + emtricitabine 200mg x one dose

Also known as: Truvada

1

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Twelve adult (18 years or older) healthy volunteers will be recruited to participate in the study. A total of 6 men and 6 women will be enrolled. Subjects of all races and ethnicities may participate, provided they meet study inclusion/exclusion criteria.

You may qualify if:

• Must be above 18 years of age and less than 50 years of age
• Able and willing to provide written informed consent to take part in the study
• Able and willing to provide adequate information for locator purposes
• Must be in good general health by volunteer history without any clinically significant systemic disease, full physical examination including blood pressure and pulse rate measurement and clinical laboratory tests
• HIV-1 status antibody negative as documented at screening
• Able to comply with all study procedures throughout the duration of study participation
• Able to comply with Lifestyle Guidelines throughout the duration of study participation
• (Males Only)
• Willing to abstain from any sexual activity including intercourse, masturbation, oral contact with the rectum, and insertion of anything per rectum for the entire duration of the study period.
• Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \> 50 kg (110 lbs).
• (Females Only)
• Must be pre-menopausal
• Must have an intact uterus and cervix
• Must have a negative serum pregnancy test at screening
• Must have negative urine pregnancy tests at day 7 and day 14

You may not qualify if:

• HIV positive at screening
• A positive result for Hepatitis B surface antigen (HbsAg) or Hepatitis B core antibody (HbcAb) screening tests or anti-hepatitis C virus serology (as determined by multi-antigen EIA)
• Active infection at the time of entry
• Active sexually transmitted disease(s)
• History of abnormal bleeding or bruising
• History of kidney disease
• History of alcoholism or drug abuse
• History of significant gastrointestinal bleeding
• History of severe or recent cardiac or pulmonary event
• Use of prescription or non-prescription drugs, vitamins, and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the baseline study visit day.
• Use of herbal supplements within 14 days of the baseline study visit day.
• Treatment with an investigational drug within 4 months preceding the baseline study visit day.
• Unwillingness to refrain from chronic use of aspirin and NSAIDS
• \> Grade 2 laboratory abnormality
• Any other clinical condition or therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Angela DM Kashuba, PharmD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Kristine B Patterson, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 30, 2011
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

US (1)