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NCT00000875 · ClinicalTrials.gov registry record · NA
Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT00000875: Clinical Trial NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000875 is a NA study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000875, a NA study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
To evaluate the safety of anti-HIV CTL therapy in early stage patients and to verify the safety when combined with antiviral therapy with zidovudine/lamivudine/indinavir and low-dose interleukin-2 (IL-2). To compare the effects on plasma and cell-associated viral load following combination drug therapy with and without antiviral CTL in early-stage patients. To study in detail the immune effects of lowering viral burden with antiviral combination drugs with and without T cell infusion on antiviral CTL activity, viral suppression and proliferation, circulating T cell phenotype, T cell apoptosis, CD4 cell numbers, DTH reaction, and inflammatory cytokine levels. In an HIV-infected person, there is an ongoing struggle between HIV replication and host immune control. In the past decade most therapeutic strategies have targeted the virus. This approach has been frustrated by viral mutation to evade drug sensitivity. Promising drugs have recently been approved and there are encouraging sustained results from combination antiviral chemotherapy. However, even the most potent drug regimens do not seem to be curative, may eventually lead to drug resistance and may not completely restore lost immune function. The addition of immune-based therapy to antiviral drugs may lead to better viral control.
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Diphenhydramine hydrochloride
- DRUG Indinavir sulfate
- DRUG Lymphocytes, Activated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Est. Completion | 2003-04 |
| Phase | NA |
Why NCT00000875 stopped before completion
NCT00000875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Zidovudine is the first listed.
NCT00000875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000875 about?
NCT00000875 is a clinical study titled "Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection". To evaluate the safety of anti-HIV CTL therapy in early stage patients and to verify the safety when combined with antiviral therapy with zidovudine/lamivudine/indinavir and low-dose interleukin-2 (IL-2). To compare the effects on plasma and cell-associated viral load following combination drug ther...
What is the current status of trial NCT00000875?
This trial is currently terminated. It is a NA study. The enrollment target is 16 participants. Estimated completion is 2003-04.
What interventions are being tested in trial NCT00000875?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Diphenhydramine hydrochloride (DRUG), Indinavir sulfate (DRUG), Lymphocytes, Activated (DRUG).
Who is sponsoring clinical trial NCT00000875?
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 NCT00000875's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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