HIV InfectionPhase 2NCT00131677
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
A Phase 2 study testing tenofovir disoproxil fumarate in people with HIV Infection, run by Centers for Disease Control and Prevention at 3 sites in United States.
Trial summary
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- tenofovir disoproxil fumarate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2005to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Fenway Community Health
Boston, Massachusetts, 02115
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Official title: Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
Read the 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
- Being tested
- tenofovir disoproxil fumarate, placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir disoproxil fumarateDrug
Also called Viread
study product taken daily
placeboDrug
study product taken daily
| Study group | Role | What they receive |
|---|---|---|
| active immediate | Active comparator | participants in this arm start study product immediately upon enrollment Receives: Drug: tenofovir disoproxil fumarate |
| placebo immediate | Placebo comparator | participants in this arm start study product immediately upon enrollment Receives: Drug: placebo |
| active delayed | Active comparator | persons in this arm start study product 9 months after enrollment Receives: Drug: tenofovir disoproxil fumarate |
| placebo delayed | Placebo comparator | participants in this arm start study product nine months after enrollment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Safety--Creatinine Elevations
Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)
Measured: 24 months (immediate arm) and 15 months (delayed arm)
Clinical Safety--Hypophosphatemia
Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)
Measured: 24 months (immediate arm), 15 months (delayed arm)
Secondary outcomes (3)
Number of Breakthrough HIV Infections
Number of participants with HIV seroconversions occuring while on study drug
Measured: 24 months (immediate arm) and 15 months (delayed arm)
Adherence to Study Drug
Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps.
Measured: 24 months (immediate arm) and 15 months (delayed arm)
Behavioral Safety--Unprotected Anal Sex (UAS)
Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study.
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startFeb 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- San Francisco Department of Public Health, AIDS Research Consortium of Atlanta
- Responsible party
- Sponsor
- Investigators
- Kata L Chillag, PhD, Principal investigator, Centers for Disease Control and PreventionLisa A Grohskopf, MD, MPH, Principal investigator, Centers for Disease Control and PreventionSusan Buchbinder, MD, Principal investigator, San Francisco Dept. of Public HealthMelanie Thompson, MD, Principal investigator, AIDS Research Consortium of AtlantaKenneth H. Mayer, MD, Principal investigator, Fenway Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131677
- Sponsor's protocol ID
- CDC-NCHHSTP-4323
- Status last verified
- Aug 2013
- First submitted
- 17 Aug 2005
- Last updated
- 10 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29315307Liu 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.
PubMed 21897852
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
- ClinicalTrials.gov ID
- NCT00131677
- Acronym / sponsor ID
- CDC-NCHHSTP-4323
- Conditions
- HIV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- San Francisco Department of Public Health, AIDS Research Consortium of Atlanta
- Study start
- Feb 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Aug 2005 (estimated)
- Results
- Posted 10 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active immediate | Active comparator | Drug: tenofovir disoproxil fumarateparticipants in this arm start study product immediately upon enrollment |
| placebo immediate | Placebo comparator | Drug: placeboparticipants in this arm start study product immediately upon enrollment |
| active delayed | Active comparator | Drug: tenofovir disoproxil fumaratepersons in this arm start study product 9 months after enrollment |
| placebo delayed | Placebo comparator | Drug: placeboparticipants in this arm start study product nine months after enrollment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenofovir disoproxil fumarateAlso: Vireadstudy product taken daily | Drug | active delayed, active immediate |
| placebostudy product taken daily | Drug | placebo delayed, placebo immediate |
Primary outcome
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)
3 secondary outcomes
Number of Breakthrough HIV Infections
Time frame: 24 months (immediate arm) and 15 months (delayed arm)
Adherence to Study Drug
Time frame: 24 months (immediate arm) and 15 months (delayed arm)
Behavioral Safety--Unprotected Anal Sex (UAS)
Time frame: Nine months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29315307Baxi 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.
- Derived from this study: PubMed 21897852Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kata L Chillag, PhD principal investigator
Centers for Disease Control and Prevention
Lisa A Grohskopf, MD, MPH principal investigator
Centers for Disease Control and Prevention
Susan Buchbinder, MD principal investigator
San Francisco Dept. of Public Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tenofovir disoproxil fumarate in people with HIV Infection, run by Centers for Disease Control and Prevention at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Safety--Creatinine Elevations (time frame: 24 months (immediate arm) and 15 months (delayed arm)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.