Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication

Withdrawn before enrolling · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00006578

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Last updated by the study team

2015-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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