Phase 2
Completed N=26
Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T
Source: ClinicalTrials.gov NCT01543152 ↗Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Apr 2021
Primary outcomePrimary: Treatment-emergent Adverse Events — 3; 6; 11; 3 participants
Summary
The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-emergent Adverse Events |
3; 6; 11; 3; 3 | — |
| SECONDARY Effect of Escalating Doses of Cyclophosphamide on SB-728-T Engraftment as Measured by CCR5 Modified CD4 Cells in Blood. |
0.038; 0.061; 0.143; 0.085; 0.079 | — |
| SECONDARY Effect of SB-728-T on Plasma HIV-1 RNA Levels Following HAART Interruption |
0; 0.250; 1.537; 0.667; 3.442 | — |
| SECONDARY Change From Baseline to Month 12 in CD4+ T-cell Counts in Peripheral Blood After Repeat Treatments With SB-728-T. (i.e. Month 12 Value - Baseline Value) |
0.064; 0.149; -0.043; 0.153; 0.099 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years of age or older with documented HIV diagnosis within 10 years of screening.
- Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption.
- Must have received at least 6 months of continuous HAART therapy and have had undetectable VLs for the preceding 3 months.
- On stable antiretroviral medication (no changes to treatment within 4 weeks of screening.
- CD4+ T-cell count ≥500 cells/µL.
- Undetectable HIV-1 RNA obtained at screening.
- ANC ≥2500/µL
- Platelet count ≥200,000/µL
Exclusion Criteria
- Acute or chronic hepatitis B or hepatitis C infection.
- Active or recent (in prior 6 months) AIDS defining complication.
- Any cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low grade (0 or 1) anal or cervical dysplasia.
- Current diagnosis of NYHA grade 3 or 4 CHF, uncontrolled angina or arrhythmias.
- History or any features on physical examination indicative of a bleeding diathesis.
- Received HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
- Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to screening.
- Use of Aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis.
- Currently participating in another clinical trial or participation in such a trial within 30 days prior to screening visit.
- Subjects who are currently taking maraviroc or have received maraviroc within 6 months prior to screening.
Data sourced from ClinicalTrials.gov (NCT01543152). 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. Informational only — not medical advice.