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rsCD4 and AZT in AIDS/ARC
NCT00000659Phase 2
Key facts
- Status
- Terminated
- Primary completion
- Jul 1990
- Countries
- 1
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- rProtein (Recombinant Protein), Biologic
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 2, randomised, open-label trial of recombinant soluble human CD4 in human immunodeficiency virus infection (HIV) (3 arms), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: HIV-1 p24 antigen levels at 16 weeks and Pharmacokinetics of rsCD4. Status: terminated.
02
Design
3 arms- Study design
- RandomizedOpen-label
Part 1A Dose Finding
Sequential assignment to AZT doses then Combo
Group 5 (AZT -> Combo)
AZT alone then AZT + rsCD4
Group 6 (Combo -> AZT)
AZT + rsCD4 then AZT alone
03
Who it enrols
Patients with AIDS or advanced ARC, CD4 count < 300 cells/mm3, and no active opportunistic infections or malignancies (except Kaposi's sarcoma).
04
Endpoints
Primary
HIV-1 p24 antigen levels
Pharmacokinetics of rsCD4
Secondary
Safety of rsCD4 and AZT
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