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NCT00000659 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00000659: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000659 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000659, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT. Parts 1B and 2: To test for additive or synergistic activity between rsCD4 and AZT as judged by falls in HIV-1 p24 antigen levels; and to evaluate the safety of rsCD4 and AZT in patients with AIDS and advanced ARC. AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT. The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4 (rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT.
Interventions
- DRUG Zidovudine
- DRUG CD4 Antigens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Phase | Phase 2 |
Why NCT00000659 stopped before completion
NCT00000659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Zidovudine is the first listed.
NCT00000659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000659 about?
NCT00000659 is a clinical study titled "A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)". Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT. Parts 1B and 2: To test for...
What is the current status of trial NCT00000659?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 80 participants.
What interventions are being tested in trial NCT00000659?
The interventions under investigation include: Zidovudine (DRUG), CD4 Antigens (DRUG).
Who is sponsoring clinical trial NCT00000659?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000659's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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