A gene transfer study using chemotherapy for adults recently diagnosed with HIV-1 who are taking antiretroviral drugs
- Conditions
- HIV-1 infectionAIDSInfection - Acquired immune deficiency syndrome (AIDS / HIV)Inflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12615000763549
- Lead Sponsor
- Calimmune Australia Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 6
1. HIV-1 diagnosis during early HIV-1 infection;
2. CD4+ T lymphocyte count >/= 500 cells/microlitre;
3. Plasma viral load < 50 copies/mL;
4. Commenced combination ART within six months of HIV-1 infection diagnosis;
5. Uninterrupted ART since initiation, and remaining on the first ART regimen;
6 HIV-1 resistance mutation testing, reporting susceptible virus to NRTI/NNRTI/PI drugs.
1. Abnormal haematology or biochemistry;
2. Detection of any CXCR4- or dual-tropic HIV-1;
3. Co-infection with hepatitis B, hepatitis C, or HTLV-1/2;
4. Latent tuberculosis infection;
5. CD4+ T lymphocyte count < 250 cells/microlitre at any time;
6. Zidovudine (AZT) within 12 weeks of study screening;
7. History of malignancy, chronic obstructive airways disease, seizure, haematological diseases, or heart failure;
8. Current or planned immunosuppressive or immunomodulatory medication;
9. Known hypersensitivity to G-CSF (Neupogen 'Registered Trademark'), plerixafor (Mozobil 'Registered Trademark'), busulfan, or any Escherichia coli-derived proteins;
10. Receipt of a vaccine for HIV-1, or any gene transfer product, at any time;
11. Individuals who will decline transfusions of any blood product;
12. Pregnancy or breastfeeding;
13. History of alcohol or drug dependence/abuse in the 12 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety and feasibility of introducing Cal-1 gene-transduced CD4+ lymphocyte and CD34+ bone marrow stem cells following chemotherapy conditioning with intravenous busulfan in HIV-1-infected adults receiving effective ART.<br><br>This is a composite outcome, assessing adverse events and correlations with the Cal-1 gene-transduced CD4+ lymphocyte and CD34+ bone marrow stem cell product dose and characteristics. This outcome is assessed by physical examinations and vital signs, complete blood counts, serum biochemistry, lymphocyte phenotyping, HIV-1 plasma viral load, and HIV-1 ART resistance genotype testing.[48weeks after receipt of the Cal-1-modified cells]
- Secondary Outcome Measures
Name Time Method