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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000875
The ClinicalTrials.gov registry entry for NCT00000875 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Zidovudine is the first listed.
NCT00000875 reports 0 study locations.
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.
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