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

NCT ID: NCT00131677

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2009-08-31

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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

active immediate

participants in this arm start study product immediately upon enrollment

Group Type: ACTIVE_COMPARATOR

tenofovir disoproxil fumarate

Intervention Type: DRUG

study product taken daily

placebo immediate

participants in this arm start study product immediately upon enrollment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

study product taken daily

active delayed

persons in this arm start study product 9 months after enrollment

Group Type: ACTIVE_COMPARATOR

tenofovir disoproxil fumarate

Intervention Type: DRUG

study product taken daily

placebo delayed

participants in this arm start study product nine months after enrollment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

study product taken daily

Interventions

tenofovir disoproxil fumarate

study product taken daily

Intervention Type: DRUG

placebo

study product taken daily

Intervention Type: DRUG

Other Intervention Names

Viread

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role: collaborator

AIDS Research Consortium of Atlanta

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kata L Chillag, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Lisa A Grohskopf, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Susan Buchbinder, MD

Role: PRINCIPAL_INVESTIGATOR

San Francisco Dept. of Public Health

Melanie Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

AIDS Research Consortium of Atlanta

Kenneth H. Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Fenway Community Health

Locations

San Francisco Department of Public Health

San Francisco, California, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Fenway Community Health

Boston, Massachusetts, United States

Countries

United States

References

Baxi SM, Vittinghoff E, Bacchetti P, Huang Y, Chillag K, Wiegand R, Anderson PL, Grant R, Greenblatt RM, Buchbinder S, Gandhi M, Liu AY. Comparing pharmacologic measures of tenofovir exposure in a U.S. pre-exposure prophylaxis randomized trial. PLoS One. 2018 Jan 9;13(1):e0190118. doi: 10.1371/journal.pone.0190118. eCollection 2018.

Reference Type: DERIVED

PMID: 29315307 (View on PubMed)

Liu AY, Vittinghoff E, Sellmeyer DE, Irvin R, Mulligan K, Mayer K, Thompson M, Grant R, Pathak S, O'Hara B, Gvetadze R, Chillag K, Grohskopf L, Buchbinder SP. Bone mineral density in HIV-negative men participating in a tenofovir pre-exposure prophylaxis randomized clinical trial in San Francisco. PLoS One. 2011;6(8):e23688. doi: 10.1371/journal.pone.0023688. Epub 2011 Aug 29.

Reference Type: DERIVED

PMID: 21897852 (View on PubMed)

Other Identifiers

CDC-NCHHSTP-4323

Identifier Type: -

Identifier Source: org_study_id