Zidovudine Levels in HIV Infected Patients Being Treated for HCV
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ClinicalTrials.gov Identifier: NCT00059358 |
Recruitment Status
:
Completed
First Posted
: April 24, 2003
Last Update Posted
: August 7, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Hepatitis C | Drug: Ribavirin plus interferon alfa-2b Drug: Ribavirin Drug: Peginterferon alfa-2b | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin |
Study Start Date : | September 2001 |
Actual Primary Completion Date : | June 2005 |
Actual Study Completion Date : | June 2005 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48
|
Drug: Ribavirin plus interferon alfa-2b
Oral tablets taken daily
Drug: Ribavirin
Oral tablet taken daily
Drug: Peginterferon alfa-2b
Subcutaneous injection
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- 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 ]

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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059358
Puerto Rico | |
UPR Adult ACTU | |
San Juan, Puerto Rico, 00936-5067 |
Principal Investigator: | Jose F. Rodriguez, PhD | MSC-UPR | |
Principal Investigator: | Jorge L. Santana, MD | MSC-UPR |
Responsible Party: | Jose F. Rodriguez, PhD, MSC-UPR |
ClinicalTrials.gov Identifier: | NCT00059358 History of Changes |
Other Study ID Numbers: |
1R01AI09141-01A1 5R01AI049141-02 ( U.S. NIH Grant/Contract ) |
First Posted: | April 24, 2003 Key Record Dates |
Last Update Posted: | August 7, 2009 |
Last Verified: | August 2009 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV HCV Ribavirin |
Interferon Co-infection Treatment experienced |
Additional relevant MeSH terms:
Hepatitis C HIV Infections Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Interferons Ribavirin Interferon-alpha Zidovudine Peginterferon alfa-2b Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |