Phase 3
N=4
Therapy to Elevate CD4 Counts in HIV-1 Disease
HIV Disease
Bottom Line
View on ClinicalTrials.gov: NCT01370018 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: CD4/CD8 Ratio — 0.44 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- alpha-1-Proteinase Inhibitor (Biological)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Institute for Human Genetics and Biochemistry
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CD4/CD8 Ratio |
0.44 | — |
Summary
For more than 20 years, alpha-1-proteinase inhibitor therapy has been the standard treatment for patients who have inherited alpha-1-proteinase inhibitor deficiency. Adult patients with this condition eventually develop emphysema. Most HIV-1 patients who have low viral load also have alpha-1-proteinase inhibitor deficiency. The number of CD4 cells in blood increases when alpha-1-proteinase inhibitor increases. Patients will be asked to participate in a pilot study to see whether the use of Zemaira® (alpha-1-proteinase inhibitor) can increase blood levels of alpha-1-proteinase inhibitor and consequently increase CD4 counts.
Eligibility Criteria
Inclusion Criteria
- HIV-1 patients must have confirmed HIV-1 disease, diagnosed using the standard criteria and be on antiretroviral therapy. Patients with inherited alpha-1 proteinase inhibitor deficiency (PIzz) must not have previously received alpha-1 proteinase inhibitor therapy. Uninfected volunteers will be age and gender matched.
- HIV-1 patients must have measurable disease, defined as HIV-1 infected patients on antiretroviral therapy with undetectable HIV RNA (<500 HIV-1 RNA copies/ml) and CD4 counts more than 200 and less than 400 cells/uL.
- Age at least 18 years and under 65 years.
- HIV-1 patients must have active alpha-1 proteinase inhibitor below 11uM (normal is 18-53 uM).
- HIV-1 patients must have one year history (prior to the study) with CD4 counts greater than 200 and less than 400 cells/uL.
- Volunteers must have no evidence of malignancy.
Exclusion Criteria
- Recent illness that will prevent the patient from participating in required study activities.
- Patients receiving other investigational agents.
- Patients with known malignancies.
- Patients with more than 500 HIV RNA copies/mL.
- Patients with more than 400 CD4 cells/uL.
- Uncontrolled illness including, but not limited to, ongoing or active infection, myeloid dysplastic syndrome, anemia, bone marrow failure, DiGeorge Syndrome, thymic disorders, or psychiatric illness/social situations that would limit compliance with study requirements.
Data sourced from ClinicalTrials.gov (NCT01370018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.