HIV InfectionsPhase 4NCT00648817
Metabolic Impact Assessment of Tenofovir Disoproxil Fumarate on Non-HIV-1 Infected Healthy Adult Male Volunteers
A Phase 4 study testing Tenofovir Disoproxil Fumarate in people with HIV Infections, run by Gilead Sciences at 1 site in United Kingdom.
Trial summary
Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg compared with placebo in non-HIV-1 infected healthy adult males. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir Disoproxil Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2006to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must have documented negative HIV serology by ELISA and P24 antigen. This will be done at the screening visit.
- Subjects must be clinically well males aged between 18 to 55 years.
- Adequate renal function:
- Calculated creatinine clearance (CrCl) >= 100 mL/min according to the Cockcroft Gault formula: Male: [(140 - age in years) x (actual body wt in kg)]/[72 x (serum creatinine in mg/dL)]= CrCl (mL/min)
- Fasting blood glucose, total cholesterol and triglycerides within normal limits
- Hepatic transaminases (AST and ALT) <= 3 x upper limit of normal (ULN)
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- Total bilirubin <= 1.5 mg/dL
- Adequate hematologic function (absolute neutrophil count >= 1,000/mm3; platelets >= 50,000/mm3; hemoglobin >= 8.0 g/dL)
- Serum amylase <= 1.5 x ULN (subjects with serum amylase > 1.5 x ULN will remain eligible if pancreatic lipase is <= 1.5 x ULN)
- Serum phosphorus >= 2.2 mg/dL
- Sexually active males must use condoms
- Life expectancy >= 1 year
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Who cannot join
- Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded
- Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
- Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
- Other metabolic syndrome or disease process likely to cause marked disturbance in glucose and lipid homeostasis
- Receiving on-going therapy with any of the following:
- Metabolically active medications
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- Any lipid-lowering medication
- Hormonal agents (oestrogens or androgens)
- Glucocorticoids
- Beta-blockers
- Thiazide diuretics
- Thyroid preparations
- Psychotropic agents
- Anabolic steroids
- Megoestrol acetate
- Nephrotoxic agents
- aminoglycoside antibiotics
- IV amphotericin B
- cidofovir
- cisplatin
- foscarnet
- IV pentamidine
- other agents with significant nephrotoxic potential
- Vancomycin
- Oral or IV ganciclovir
- Agents that inhibit or compete for elimination via active renal tubular secretion
- Probenecid
- Systemic chemotherapeutic agents (i.e., cancer treatment medications)
- Systemic corticosteroids
- Interleukin 2 (IL 2) and other immunomodulating agents
- Investigational agents
- Administration of any of the above medications must be discontinued at least 30 days prior to the baseline visit and for the duration of the study period.
- 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 subject compliance.
- Malignancy or basal cell carcinoma.
- Active, serious infections requiring parenteral antibiotic therapy within 15 days prior to screening.
- Prior history of significant renal or bone disease.
- Subjects should avoid giving blood for the duration of this study.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Two-Phase Crossover Study of the Metabolic Impact of Tenofovir Disoproxil Fumarate on HIV-1 Seronegative Healthy Adult Males
Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg compared with placebo in non-HIV-1 infected healthy adult males. Additionally, endothelial function, adipocytokines and lipids will be monitored.
Read the detailed description
Double-blind, randomized, placebo-controlled study using a two-sequence two-period crossover structure. Sixteen HIV-1-negative males will be randomized 1:1 to one of two treatment arms.
Group 1:
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the first 14 days of the study.
- Tenofovir DF placebo tablet QD for the last 14 days of the study.
Group 2:
- Tenofovir DF placebo tablet QD for the first 14 days of the study.
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the last 14 days of the study.
Physical examinations and laboratory analyses are conducted at screening, baseline, Day 14, and Day 28. A euglycaemic clamp protocol and an ECG are performed at the baseline, Day 14 and Day 28 visits.
The primary efficacy endpoint of this study is insulin-mediated glucose disposal during a hyperinsulinaemic euglycaemic clamp study. Endothelial function will be monitored by Selectin P/E and PAI-1 levels; adipocytokine levels will be monitored by measuring adiponectin and leptin levels; and lipid subfractions, including cholesterol (large and small subfractions of HDL and LDL) triglycerides and non-esterified fatty acids will be measured. Safety will be evaluated by adverse event and clinical laboratory test reporting.
- Conditions
- HIV Infections
- Being tested
- Tenofovir Disoproxil Fumarate, Tenofovir DF placebo
- Keywords
- HIV-1, tenofovir DF
- 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
Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil)
Tenofovir DF placeboDrug
Tenofovir DF placebo tablet QD
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | * Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the first 14 days of the study.
* Tenofovir DF placebo tablet QD for the last 14 days of the study. Receives: Drug: Tenofovir Disoproxil Fumarate; Drug: Tenofovir DF placebo |
| Group 2 | Active comparator | * Tenofovir DF placebo tablet QD for the first 14 days of the study.
* Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the last 14 days of the study. Receives: Drug: Tenofovir Disoproxil Fumarate; Drug: Tenofovir DF placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact on insulin sensitivity (determined by peripheral glucose uptake suing a euglycaemic clamp) of the administration of tenofovir DF compared with placebo for two weeks in HIV-1 seronegative healthy male volunteers.
Secondary outcomes (3)
To assess endothelial function by monitoring changes in Selectin P/E and PAI-1 assays.
To monitor adipocytokines by assessing adiponectin and leptin levels.
To monitor lipids by assessing large and small lipoprotein sub-fractions of HDL and LDL cholesterol, triglycerides, and non esterified fatty acid concentrations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJul 2006
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Graeme Moyle, MD, MB, BS, DipGUM, Principal investigator, Chelsea and Westminster Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648817
- Sponsor's protocol ID
- GS-US-104-0318
- Other IDs
- EUDRACT Number: 2004-005083-25
- Status last verified
- Mar 2008
- First submitted
- 27 Mar 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Two-Phase Crossover Study of the Metabolic Impact of Tenofovir Disoproxil Fumarate on HIV-1 Seronegative Healthy Adult Males
- ClinicalTrials.gov ID
- NCT00648817
- Acronym / sponsor ID
- GS-US-104-0318
- Conditions
- HIV Infections
- Keywords
- HIV-1, tenofovir DF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg compared with placebo in non-HIV-1 infected healthy adult males. Additionally, endothelial function, adipocytokines and lipids will be monitored.
Detailed description
Double-blind, randomized, placebo-controlled study using a two-sequence two-period crossover structure. Sixteen HIV-1-negative males will be randomized 1:1 to one of two treatment arms.
Group 1:
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the first 14 days of the study.
- Tenofovir DF placebo tablet QD for the last 14 days of the study.
Group 2:
- Tenofovir DF placebo tablet QD for the first 14 days of the study.
- Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the last 14 days of the study.
Physical examinations and laboratory analyses are conducted at screening, baseline, Day 14, and Day 28. A euglycaemic clamp protocol and an ECG are performed at the baseline, Day 14 and Day 28 visits.
The primary efficacy endpoint of this study is insulin-mediated glucose disposal during a hyperinsulinaemic euglycaemic clamp study. Endothelial function will be monitored by Selectin P/E and PAI-1 levels; adipocytokine levels will be monitored by measuring adiponectin and leptin levels; and lipid subfractions, including cholesterol (large and small subfractions of HDL and LDL) triglycerides and non-esterified fatty acids will be measured. Safety will be evaluated by adverse event and clinical laboratory test reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Tenofovir Disoproxil Fumarate, Drug: Tenofovir DF placebo* Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the first 14 days of the study. * Tenofovir DF placebo tablet QD for the last 14 days of the study. |
| Group 2 | Active comparator | Drug: Tenofovir Disoproxil Fumarate, Drug: Tenofovir DF placebo* Tenofovir DF placebo tablet QD for the first 14 days of the study. * Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the last 14 days of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects must have documented negative HIV serology by ELISA and P24 antigen. This will be done at the screening visit.
- Subjects must be clinically well males aged between 18 to 55 years.
- Adequate renal function:
- Calculated creatinine clearance (CrCl) >= 100 mL/min according to the Cockcroft Gault formula: Male: [(140 - age in years) x (actual body wt in kg)]/[72 x (serum creatinine in mg/dL)]= CrCl (mL/min)
- Fasting blood glucose, total cholesterol and triglycerides within normal limits
Key exclusion criteria (39 listed)
- Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded
- Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
- Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
- Other metabolic syndrome or disease process likely to cause marked disturbance in glucose and lipid homeostasis
- Receiving on-going therapy with any of the following:
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 FumarateTenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) | Drug | Group 1, Group 2 |
| Tenofovir DF placeboTenofovir DF placebo tablet QD | Drug | Group 1, Group 2 |
Primary outcome
To assess the impact on insulin sensitivity (determined by peripheral glucose uptake suing a euglycaemic clamp) of the administration of tenofovir DF compared with placebo for two weeks in HIV-1 seronegative healthy male volunteers.
3 secondary outcomes
To assess endothelial function by monitoring changes in Selectin P/E and PAI-1 assays.
To monitor adipocytokines by assessing adiponectin and leptin levels.
To monitor lipids by assessing large and small lipoprotein sub-fractions of HDL and LDL cholesterol, triglycerides, and non esterified fatty acid concentrations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
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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.
Graeme Moyle, MD, MB, BS, DipGUM principal investigator
Chelsea and Westminster Hospital, London, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir Disoproxil Fumarate in people with HIV Infections, run by Gilead Sciences at 1 site in United Kingdom.
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 13 inclusion and 39 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 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the impact on insulin sensitivity (determined by peripheral glucose uptake suing a euglycaemic clamp) of the administration of tenofovir DF compared with placebo for two weeks in HIV-1 seronegative healthy male volunteers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2008.