HIV InfectionPhase 4NCT01285050
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
A Phase 4 study testing Antiretroviral therapy (ART), raltegravir and Emtricitabine and tenofovir disoproxil fumarate in people with HIV Infection and Hepatitis C, run by Johns Hopkins University at 1 site in United States.
Trial summary
The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV Infection, Hepatitis C
- What is being tested?
- Antiretroviral therapy (ART), raltegravir and Emtricitabine and tenofovir disoproxil fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2015
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Human
- Able to provide written informed consent
- HIV antibody positive
- HIV viral load positive
- HIV treatment naive
- Hepatitis C antibody positive
Show all 10Show fewer
- Hepatitis C viral load positive
- Hepatitis C treatment naive
- Approved to take HIV medications for minimum 9 months
- Willing to use contraception, Life expectancy greater than 2 years
Who cannot join
- Significant opportunistic infections within 12 month
- Hepatitis B positive
- Evidence of liver cirrhosis
- Decompensated liver disease
- Chronic alcohol abuse
- Allergy to raltegravir, tenofovir, and/or emtricitabine
Show all 18Show fewer
- Active or suspected malignancy
- Sarcoidosis
- Active TB
- Coronary artery disease
- Uncontrolled seizures
- Untreated thyroid disease
- Untreated diabetes
- Weight greater than 125 kg
- Severe depression or severe psychiatric disorder
- Ongoing alcohol or illicit drug use
- Pregnant, nursing, pr planning to become pregnant
- Allergy to interferon
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy
The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).
Read the detailed description
We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.
- Conditions
- HIV Infection, Hepatitis C
- Being tested
- Antiretroviral therapy (ART), raltegravir, Emtricitabine and tenofovir disoproxil fumarate
- Keywords
- HIV, Human immunodeficiency virus, Acquired Immune Deficiency Syndrome Virus, AIDS Virus, Immunodeficiency Virus, Human, Virus, Human Immunodeficiency, Hepatitis C, Hepatitis C, chronic, Hepatitis C virus, Hepatitis C antibodies, Hepatitis C antigens
- Medical subject headings
- HIV Infections, Hepatitis C, Acquired Immunodeficiency Syndrome, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiretroviral therapy (ART)Drug
Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate.
raltegravirDrug
Also called Isentress
raltegravir is an HIV medication given 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarateDrug
Also called Truvada
Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
| Study group | Role | What they receive |
|---|---|---|
| pre post ART | Other | HCV and HIV viral load pre and post antiretroviral therapy (ART). ART is the intervention and the comparison is the HIV and HCV viral load reductions as determined by RT-PCR after administration of interferon alfa in each instance (before and after ART) Receives: Drug: Antiretroviral therapy (ART); Drug: raltegravir; Drug: Emtricitabine and tenofovir disoproxil fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA
HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.
Measured: 48 hours after interferon administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2015
- Study completionApr 2015
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.
- More trials run by Johns Hopkins UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, David Thomas, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285050
- Sponsor's protocol ID
- NA00040361
- Other IDs
- R01DA013806
- Status last verified
- Oct 2016
- First submitted
- 26 Jan 2011
- Last updated
- 29 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kandathil AJ, Breitwieser FP, Sachithanandham J, Robinson M, Mehta SH, Timp W, Salzberg SL, Thomas DL, Balagopal A. Presence of Human Hepegivirus-1 in a Cohort of People Who Inject Drugs. Ann Intern Med. 2017 Jul 4;167(1):1-7. doi: 10.7326/M17-0085. Epub 2017 Jun 6.
PubMed 28586923El-Diwany R, Breitwieser FP, Soliman M, Skaist AM, Srikrishna G, Blankson JN, Ray SC, Wheelan SJ, Thomas DL, Balagopal A. Intracellular HIV-1 RNA and CD4+ T-cell activation in patients starting antiretrovirals. AIDS. 2017 Jun 19;31(10):1405-1414. doi: 10.1097/QAD.0000000000001480.
PubMed 28358734
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT01285050
- Acronym / sponsor ID
- NA00040361
- Conditions
- HIV Infection, Hepatitis C
- Keywords
- HIV, Human immunodeficiency virus, Acquired Immune Deficiency Syndrome Virus, AIDS Virus, Immunodeficiency Virus, Human, Virus, Human Immunodeficiency, Hepatitis C, Hepatitis C, chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Posted 29 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).
Detailed description
We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre post ART | Other | Drug: Antiretroviral therapy (ART), Drug: raltegravir, Drug: Emtricitabine and tenofovir disoproxil fumarateHCV and HIV viral load pre and post antiretroviral therapy (ART). ART is the intervention and the comparison is the HIV and HCV viral load reductions as determined by RT-PCR after administration of interferon alfa in each instance (before and after ART) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult Human
- Able to provide written informed consent
- HIV antibody positive
- HIV viral load positive
- HIV treatment naive
Key exclusion criteria (18 listed)
- Significant opportunistic infections within 12 month
- Hepatitis B positive
- Evidence of liver cirrhosis
- Decompensated liver disease
- Chronic alcohol abuse
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 |
|---|---|---|
| Antiretroviral therapy (ART)Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate. | Drug | pre post ART |
| raltegravirAlso: Isentressraltegravir is an HIV medication given 400 mg twice daily by mouth | Drug | pre post ART |
| Emtricitabine and tenofovir disoproxil fumarateAlso: TruvadaEmtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth | Drug | pre post ART |
Primary outcome
HCV RNA
Time frame: 48 hours after interferon administration
HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28586923Kandathil AJ, Breitwieser FP, Sachithanandham J, Robinson M, Mehta SH, Timp W, Salzberg SL, Thomas DL, Balagopal A. Presence of Human Hepegivirus-1 in a Cohort of People Who Inject Drugs. Ann Intern Med. 2017 Jul 4;167(1):1-7. doi: 10.7326/M17-0085. Epub 2017 Jun 6.
- Derived from this study: PubMed 28358734El-Diwany R, Breitwieser FP, Soliman M, Skaist AM, Srikrishna G, Blankson JN, Ray SC, Wheelan SJ, Thomas DL, Balagopal A. Intracellular HIV-1 RNA and CD4+ T-cell activation in patients starting antiretrovirals. AIDS. 2017 Jun 19;31(10):1405-1414. doi: 10.1097/QAD.0000000000001480.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Antiretroviral therapy (ART), raltegravir and Emtricitabine and tenofovir disoproxil fumarate in people with HIV Infection and Hepatitis C, run by Johns Hopkins University at 1 site 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 10 inclusion and 18 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 29 Nov 2016. 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 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. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2016). 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?
HCV RNA (time frame: 48 hours after interferon administration). 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 NCT01285050, 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 29 Nov 2016.