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Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00131677
Recruitment Status : Completed
First Posted : August 19, 2005
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Collaborators:
San Francisco Department of Public Health
AIDS Research Consortium of Atlanta
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE August 17, 2005
First Posted Date  ICMJE August 19, 2005
Results First Submitted Date  ICMJE August 8, 2013
Results First Posted Date  ICMJE March 10, 2014
Last Update Posted Date March 10, 2014
Study Start Date  ICMJE February 2005
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • Clinical Safety--Creatinine Elevations [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]
    Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)
  • Clinical Safety--Hypophosphatemia [ Time Frame: 24 months (immediate arm), 15 months (delayed arm) ]
    Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2005)
Clinical and behavioral safety
Change History Complete list of historical versions of study NCT00131677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • Number of Breakthrough HIV Infections [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]
    Number of participants with HIV seroconversions occuring while on study drug
  • Adherence to Study Drug [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]
    Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps.
  • Behavioral Safety--Unprotected Anal Sex (UAS) [ Time Frame: Nine months ]
    Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2005)
  • Number of HIV infections
  • Genetic characteristics of HIV-1 breakthrough viruses
  • Participants' adherence with daily TDF
Current Other Pre-specified Outcome Measures
 (submitted: January 22, 2014)
>5% Bone Mineral Density Decline at Femoral Neck [ Time Frame: 24 months (immediate arm), 15 months (delayed arm) ]
Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
Official Title  ICMJE Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
Brief Summary The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
Detailed Description This study will assess the clinical and behavioral safety and tolerability of oral daily TDF use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in uninfected men.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • Drug: tenofovir disoproxil fumarate
    study product taken daily
    Other Name: Viread
  • Drug: placebo
    study product taken daily
Study Arms  ICMJE
  • Active Comparator: active immediate
    participants in this arm start study product immediately upon enrollment
    Intervention: Drug: tenofovir disoproxil fumarate
  • Placebo Comparator: placebo immediate
    participants in this arm start study product immediately upon enrollment
    Intervention: Drug: placebo
  • Active Comparator: active delayed
    persons in this arm start study product 9 months after enrollment
    Intervention: Drug: tenofovir disoproxil fumarate
  • Placebo Comparator: placebo delayed
    participants in this arm start study product nine months after enrollment
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2005)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy biologic male (male at birth)
  • 18-60 years of age
  • HIV-1 negative by licensed, commercially available, FDA-approved whole blood rapid enzyme immunoassay (EIA) at screening and enrollment
  • Reports any anal sex with a man in the last 12 months
  • Able to understand and pass comprehension assessment questionnaire
  • Able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Able to understand English
  • Adequate renal function: calculated creatinine clearance of at least 70 mL/min
  • Hepatic transaminases (AST and ALT) less than or equal to 2x upper limit of normal (ULN)
  • Total bilirubin less than or equal to 1.5 mg/dL
  • Absolute neutrophil count at least 1,500/mm3;
  • Platelets at least 100,000/mm3;
  • Hemoglobin at least 9.5 g/dL
  • Serum amylase less than or equal to 1.5 x ULN
  • Biochemical profile: within normal limits for serum phosphorus, potassium, sodium, and calcium.
  • Hepatitis B surface antigen negative
  • Normal urine dipstick or urinalysis (UA)

Exclusion Criteria:

  • Active untreated syphilis
  • Current uncontrolled hypertension (blood pressure > 160/100 mmHg)
  • Mutually monogamous for > one year with a known HIV antibody negative partner
  • History of chronic renal disease, known osteoporosis, osteomalacia, or osteopenia
  • Current or expected participation in other longitudinal HIV behavioral or biomedical research study
  • Current HIV antiretroviral use
  • Receiving or planning to receive on-going therapy with any nephrotoxic agents or experimental/investigational agents
  • Previous or expected requirements for the administration of immunosuppressive/ immunomodulatory therapy (e.g. chronic systemic steroids, interferon, interleukins, chemotherapy, radiation).
  • Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
  • Imminently life-threatening medical conditions (malignancy, immunosuppressive disease [e.g. lymphoma]), or other serious disease or conditions (e.g. cardiovascular, renal, diabetes) within the last 5 years or that are unstable and/or require chronic medication that would impede compliance with study requirements and complicate the interpretation of adverse events
  • Expected to be non-compliant with study visits or planning to move within 24 months to an area where the study will not be conducted
  • Any other clinical or social condition, prior therapy, occupation, or other responsibility, that, in the opinion of the investigator, would interfere with, or serve as a contraindication to study participation or compliance with the dosing requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00131677
Other Study ID Numbers  ICMJE CDC-NCHHSTP-4323
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centers for Disease Control and Prevention
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE
  • San Francisco Department of Public Health
  • AIDS Research Consortium of Atlanta
Investigators  ICMJE
Principal Investigator: Kata L Chillag, PhD Centers for Disease Control and Prevention
Principal Investigator: Lisa A Grohskopf, MD, MPH Centers for Disease Control and Prevention
Principal Investigator: Susan Buchbinder, MD San Francisco Dept. of Public Health
Principal Investigator: Melanie Thompson, MD AIDS Research Consortium of Atlanta
Principal Investigator: Kenneth H. Mayer, MD Fenway Community Health
PRS Account Centers for Disease Control and Prevention
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP