HIV InfectionsPhase 1/2NCT00059358
Zidovudine Levels in HIV Infected Patients Being Treated for HCV
A Phase 1/2 study testing Ribavirin plus interferon alfa-2b, Ribavirin and Peginterferon alfa-2b in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Puerto Rico.
Trial summary
This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients who are also being treated for hepatitis C virus (HCV) infection. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- HIV Infections, Hepatitis C
- What is being tested?
- Ribavirin plus interferon alfa-2b, Ribavirin and Peginterferon alfa-2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Sep 2001to Jun 2005
- Phase
- Phase 1/2
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HCV-infected
- HIV-1 infection
- CD4 cell count > 200 cells/mm³ within 30 days prior to study entry
- HIV RNA < 400 copies/ml within 90 days of study entry
- Use of zidovudine, lamivudine, and any PI and/or NNRTI
- ANC value >= 1,500 ml³ within 30 days of study entry
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- Weight > 50 kg (110 lbs) for women and > 60 kg (132 lbs) for men
- Acceptable methods of contraception
- Ability and willingness to complete the Baseline Adherence Questionnaire
- Documentation of adherence confirmed by the Baseline Adherence Questionnaire and certified by the study officials
Who cannot join
- Previous ribavirin therapy
- More than 2 months of interferon therapy
- Current use of any NRTI other than ZDV and 3TC
- Hepatitis B surface antigen positive
- Infectious, autoimmune, tumoral, biliary, or vascular liver disease
- Alcohol consumption of more than 50 g/day
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- Current use of intravenous drugs
- Hemoglobin levels < 10 gm/dl
- Methadone use
- Chemotherapy
- Certain medications
- Acute opportunistic or bacterial infection requiring therapy at the time of enrollment
- Hemoglobinopathy (e.g., thalassemia) or any other cause of tendency to hemolysis
- Psychiatric disorders, severe depression, history of suicide attempts, or suicidal ideation
- Renal disease requiring dialysis
- Significant coronary diseases or two or more risk factors for coronary diseases, such as > 55 years old, hypertension, and cholesterol > 250 mg/dl
- Any clinically significant diseases (other than HIV and HCV infection) that, in the opinion of study officials, would compromise the outcome of this study
- Pregnancy
- Participation in blinded clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin
This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients who are also being treated for hepatitis C virus (HCV) infection.
Read the detailed description
An estimated 50,000 people in Puerto Rico are infected with HCV. HIV and HCV have similar routes of transmission, and HCV co-infection occurs in 8% to 23% of HIV infected patients. Researchers have shown that treatment for HCV with Rebetron (ribavirin plus interferon alfa-2b) significantly decreases HCV viral load without affecting HIV viral load. However, measurements of intracellular levels of the active forms of zidovudine (ZDV-MP and ZDV-TP) were not performed. Such measurements are needed to provide a more rational basis for dosing in HIV/HCV co-infected patients. This study will investigate the intracellular exposure to active ZDV metabolites prior to and after treatment with Rebetron or treatment with PEG-Intron (pegylated interferon) and ribavirin.
Participants in this study will remain on their usual antiretroviral regimen; no changes may be made to that regimen for the first 4 weeks of the study. Upon study entry, participants will have intracellular pharmacokinetic studies. During Week 2, participants will start either Rebetron or PEG-Intron plus ribavirin therapy, will have intracellular pharmacokinetic studies, and will undergo liver biopsy. Additional intracellular pharmacokinetic studies will be performed at Weeks 12 and 24. Rebetron or PEG-Intron plus ribavirin will be given for 48 weeks. A second liver biopsy will be performed 24 weeks after discontinuing Rebetron or PEG-Intron plus ribavirin therapy. Participants will be followed for 72 weeks.
- Conditions
- HIV Infections, Hepatitis C
- Being tested
- Ribavirin plus interferon alfa-2b, Ribavirin, Peginterferon alfa-2b
- Keywords
- HIV, HCV, Ribavirin, Interferon, Co-infection, Treatment experienced
- Medical subject headings
- HIV Infections, Hepatitis C, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ribavirin plus interferon alfa-2bDrug
Oral tablets taken daily
RibavirinDrug
Oral tablet taken daily
Peginterferon alfa-2bDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48 Receives: Drug: Ribavirin plus interferon alfa-2b; Drug: Ribavirin; Drug: Peginterferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state area under the concentration time curve (AUC) between 0 and 12 hours of zidovudine (ZDV)-MP, ZDV-TP, and dTTP in PBMCs from HIV and hepatitis C virus (HCV) coinfected patients before and after peginterferon alfa-2b with or without ribavirin
Measured: Throughout study
Systemic exposure (AUC over 0 to 12 hours) of nelfinavir before and after peginterferon alfa-2b with or without ribavirin in HIV and HCV coinfected patients
Measured: Throughout study
Effect of peginterferon alfa-2b with or without ribavirin in HCV RNA viral titers, alanine aminotransferase (ALT) levels, CD4+, and HIV-RNA viral titers in HIV and HCV coinfected patients
Measured: Through Week 48
Effect of peginterferon alfa-2b with or without ribavirin on liver histology
Measured: At Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2003 (estimated)
- Study startSep 2001
- Primary completionJun 2005
- Study completionJun 2005
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 National Institute of Allergy and Infectious Diseases (NIAID)The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Jose F. Rodriguez, PhD, Principal investigator, MSC-UPRJorge L. Santana, MD, Principal investigator, MSC-UPR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059358
- Sponsor's protocol ID
- 1R01AI09141-01A1
- Other IDs
- 5R01AI049141-02
- Status last verified
- Aug 2009
- First submitted
- 23 Apr 2003
- Last updated
- 7 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin
- ClinicalTrials.gov ID
- NCT00059358
- Acronym / sponsor ID
- 1R01AI09141-01A1
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- HIV, HCV, Ribavirin, Interferon, Co-infection, Treatment experienced
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2001
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 24 Apr 2003 (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.
This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients who are also being treated for hepatitis C virus (HCV) infection.
Detailed description
An estimated 50,000 people in Puerto Rico are infected with HCV. HIV and HCV have similar routes of transmission, and HCV co-infection occurs in 8% to 23% of HIV infected patients. Researchers have shown that treatment for HCV with Rebetron (ribavirin plus interferon alfa-2b) significantly decreases HCV viral load without affecting HIV viral load. However, measurements of intracellular levels of the active forms of zidovudine (ZDV-MP and ZDV-TP) were not performed. Such measurements are needed to provide a more rational basis for dosing in HIV/HCV co-infected patients. This study will investigate the intracellular exposure to active ZDV metabolites prior to and after treatment with Rebetron or treatment with PEG-Intron (pegylated interferon) and ribavirin.
Participants in this study will remain on their usual antiretroviral regimen; no changes may be made to that regimen for the first 4 weeks of the study. Upon study entry, participants will have intracellular pharmacokinetic studies. During Week 2, participants will start either Rebetron or PEG-Intron plus ribavirin therapy, will have intracellular pharmacokinetic studies, and will undergo liver biopsy. Additional intracellular pharmacokinetic studies will be performed at Weeks 12 and 24. Rebetron or PEG-Intron plus ribavirin will be given for 48 weeks. A second liver biopsy will be performed 24 weeks after discontinuing Rebetron or PEG-Intron plus ribavirin therapy. Participants will be followed for 72 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ribavirin plus interferon alfa-2b, Drug: Ribavirin, Drug: Peginterferon alfa-2bParticipants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- HCV-infected
- HIV-1 infection
- CD4 cell count > 200 cells/mm³ within 30 days prior to study entry
- HIV RNA < 400 copies/ml within 90 days of study entry
- Use of zidovudine, lamivudine, and any PI and/or NNRTI
Key exclusion criteria (19 listed)
- Previous ribavirin therapy
- More than 2 months of interferon therapy
- Current use of any NRTI other than ZDV and 3TC
- Hepatitis B surface antigen positive
- Infectious, autoimmune, tumoral, biliary, or vascular liver disease
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 |
|---|---|---|
| Ribavirin plus interferon alfa-2bOral tablets taken daily | Drug | 1 |
| RibavirinOral tablet taken daily | Drug | 1 |
| Peginterferon alfa-2bSubcutaneous injection | Drug | 1 |
Primary outcome
Steady state area under the concentration time curve (AUC) between 0 and 12 hours of zidovudine (ZDV)-MP, ZDV-TP, and dTTP in PBMCs from HIV and hepatitis C virus (HCV) coinfected patients before and after peginterferon alfa-2b with or without ribavirin
Time frame: Throughout study
Systemic exposure (AUC over 0 to 12 hours) of nelfinavir before and after peginterferon alfa-2b with or without ribavirin in HIV and HCV coinfected patients
Time frame: Throughout study
Effect of peginterferon alfa-2b with or without ribavirin in HCV RNA viral titers, alanine aminotransferase (ALT) levels, CD4+, and HIV-RNA viral titers in HIV and HCV coinfected patients
Time frame: Through Week 48
Effect of peginterferon alfa-2b with or without ribavirin on liver histology
Time frame: At Week 72
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 7 Aug 2009.
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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.
Jose F. Rodriguez, PhD principal investigator
MSC-UPR
Jorge L. Santana, MD principal investigator
MSC-UPR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ribavirin plus interferon alfa-2b, Ribavirin and Peginterferon alfa-2b in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Puerto Rico.
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 19 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 7 Aug 2009. 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 Puerto Rico. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Steady state area under the concentration time curve (AUC) between 0 and 12 hours of zidovudine (ZDV)-MP, ZDV-TP, and dTTP in PBMCs from HIV and hepatitis C virus (HCV) coinfected patients before and after peginterferon alfa-2b with or without ribavirin (time frame: Throughout study). The study lists 4 primary outcomes in all. 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 7 Aug 2009.