Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication
Evaluation of the Relationship Between Immunologic Recovery After Highly Active Antiretroviral Therapy and the Ability to Mobilize CD34+ Stem Cells Following G-CSF Administration
3 other identifiers
interventional
N/A
1 country
5
Brief Summary
The purpose of this study is to see if the amount of stem cells (cells that can develop into many kinds of cells) in the blood before anti-HIV drugs are taken can predict if the immune system will become stronger after anti-HIV drugs are given and if anti-HIV drugs can restore stem cells. HIV infection has been shown to cause stem cells not to function well. Granulocyte colony-stimulating factor (G-CSF), which causes stem cells to go from the bone marrow (tissues in the bones where blood cells are formed) into the bloodstream, could possibly help boost immunity after anti-HIV treatment. This study examines the effects of G-CSF in helping the immune system become stronger after beginning anti-HIV treatment.
Trial Health
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5 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 9, 2015
June 1, 2003
December 1, 2000
March 5, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 18 years of age.
- Have HIV levels of at least 1,000 copies/ml within 28 days prior to study entry.
- Have a CD4 cell count of 500 cells/mm3 or less in the 28 days prior to study entry.
- Have not had anti-HIV therapy or have had no more than 2 weeks of prior anti-HIV therapy 90 days prior to study entry.
- Are a good candidate for anti-HIV therapy.
- Agree to abstinence or use a barrier method of birth control during the study and for 12 weeks afterward.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have ever had cancer.
- Have used G-CSF or GM-CSF within 180 days prior to study entry.
- Are allergic to E. coli products (such as insulin or human growth hormone).
- Abuse drugs or alcohol.
- Are receiving or have had, within 14 days prior to study entry, treatment for an opportunistic (AIDS-related) infection.
- Have a medical condition that would interfere with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cara Wilson
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 1, 2000
First Posted
August 31, 2001
Last Updated
March 9, 2015
Record last verified: 2003-06