Single Dose Truvada in HIV-negative Men and Women

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Gilead Sciences
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• 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

• Must have regular menstrual cycles (minimum of 26 and maximum of 35 days)

• Must be at least 2 months since last pregnancy outcome and have had at least two spontaneous menses

• Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight > 50 kg (110 lbs).

• Must abstain from use of intravaginal products including tampons, spermicides, lubricants, vaginal hygiene products, diaphragms, and cervical caps, for 72 hours prior to the baseline study visit and through 21 days after the baseline study visit.

• Must abstain from any sexual activity including intercourse, oral contact with the female genitalia, masturbation, and penetration of the vagina by fingers, tampons, sex toys, or any other objects for 72 hours prior to the baseline study visit (Day 0) and through 19 days after the baseline study visit.

Exclusion Criteria:

• 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.

• Unwilling or unable to comply with the lifestyle guidelines for the entire duration of study participation. The lifestyle guidelines are outlined in Appendix A.

• Allergy to local anesthetics (lidocaine) or silver nitrate or iron-containing substances

(Males Only)

• Active rectal infection at screen

• History of inflammatory bowel disease

• History or symptoms of gastrointestinal disease

(Females Only)

• Currently pregnant or at risk for pregnancy (may be using Paragard® IUD, effective barrier method, female sterilization or abstinence, or be sexually active with a vasectomized partner)

• Currently breastfeeding

• Positive test for Neisseria gonorrhoea, Chlamydia trachomatis, Trichomonas vaginalis or syphilis at screen.

• Use of any hormonal contraceptives within 30 days of enrollment.

• Use of Depo-Provera within 120 days of enrollment.

• Current vaginal or urinary tract infection