Harry B Greenberg
Blood Sample Study of viral and Immune Responses to Treatment in People with HIV or Hepatitis C Infections
Contact Information
VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Brief
You are being invited to participate in this study because you have human immunodeficiency virus (HIV) infection or you have hepatitis C virus (HCV) infection or both HIV and HCV infection. 20 HIV infected men and/or women, 40 HIV/HCV co-infected men and/or women and 20 HCV infected men and/or women will participate in this study. If you have evidence of HIV and/or the HCV virus in your blood, we would like to examine your blood.. We are trying to determine if HCV treatment or HIV treatment makes the immune system respond differently. We will also try to detemine if the amount or type of HCV virus changes over time in people infected with only HCV virus compared to those who have both HIV and HCV infection. We will examine your blood samples to answer these questions.
Recruiting Status:
RecruitingStanford Recruiting Status:
Condition(s):
Intervention(s):
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Arm 1
1. HIV antibody and/or HIV viral load positive prior to or at baseline
2. Ability to give informed consent
3. Male or female age > 18 years
4. Has never taken antivirals (ARVs) for treatment of HIV
5. Willing to start ARVs if on treatment arm (group A)
6. HCV Antibody negative
7. Not known to be HBV co-infected
Arm 2
1. HIV antibody and/or HIV viral load positive prior to or at baseline
2. HCV antibody and/or HCV viral load positive prior to or at baseline
3. Ability to give informed consent
4. Male or female > 18 years
5. Willing to start ARVs if on treatment arm (group A)
6. No HCV treatment or intent
7. Not known to be HBV co-infected
Arm 3
1. HIV antibody and/or HIV viral load positive prior to or at baseline
2. HCV antibody and/or HCV viral load positive prior to or at baseline
3. Ability to give informed consent
4. Male or female age > 18 years
5. On highly active antiretroviral therapy (HAART)
6. Willing to start treatment for HCV if on treatment arm (group A)
7. Not known to be HBV co-infected
8. Participation in this study is allowable if experimental HCV drug therapy is to be administered to the subject in another ongoing clinical trial and if it is agreeable with the other sponsor.
Arm 4
1. HCV antibody and/or HCV viral load positive prior to or at baseline
2. HIV antibody negative
3. Ability to give informed consent
4. Male or female age > 18 years
5. Has never taken HCV treatment and willing to start if on treatment arm
(Group A)
6. Not known to be HBV co-infected
7. Participation in this study is allowable if experimental HCV drug therapy is to be administered to the subject in another ongoing clinical trial and if it is agreeable with the other sponsor.
Key Exclusion Criteria:
1. Hemoglobin < 9.l gm/dL
2. ANC < 1000/mm3
3. Platelets < 75,000/mm3
4. Women who are pregnant or breast feeding
5. Use of immunomodulating drugs
6. Organ transplant
7. Decompensated liver disease (i.e. Childs class C)
8. Serious illnesses, or any other clinical condition that in the opinion of the investigator would compromise the study or findings.
Additional Study Details
Official Title:
Evaluation of Viral and Immune Responses to Treatment in People with HIV or HCV InfectionsAnticipated start date:
4/24/2007Lead Sponsor:
Department of Veterans AffairsInvestigator(s):
Study Type:
ObservationalPurpose:
NOTNEEDEDDuration:
LongitudinalSelection:
Defined PopulationTiming:
Retrospective/ProspectiveTotal Number to be Enrolled:
80Total Number to be Enrolled at Stanford:
0More Information
Secondary ID(s):
- Stanford IRB 97954
Locations & Contacts
Stanford Locations & Contacts:
VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
4/15/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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