- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000875
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 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.
Study Overview
Status
Conditions
Detailed Description
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.
This study has 2 regimens of 8 patients each. Patients are randomized as to CTL infusion only. Patients are stratified by viral load (less than 10,000 copies/ml vs. greater than or equal to 10,000 copies/ml). All patients receive combination drug therapy with AZT/3TC/indinavir for 9 months at which time patients have the option of continuing their study regimen another year or changing therapy. Patients in the T cell treatment regimen (regimen 2) receive 2 infusions of ex vivo expanded autologous anti-HIV CTL at 3 and 6 months after beginning AZT/3TC/indinavir therapy. The second infusion is administered with low-dose sc IL-2 1 day before and 4 days following T cell infusion.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- The Ctr For Blood Research Inc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- Serologically confirmed HIV-1 infection.
- CD4 count >= 400/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following conditions or symptoms are excluded:
- Symptoms of HIV-1 disease, except lymphadenopathy.
- Symptoms of cardiac disease.
- Evidence of clinical pulmonary disease.
- Significant medical disease.
Patients with any of the following prior conditions are excluded:
- History of symptoms of HIV-1 disease, except lymphadenopathy.
- Participation in another experimental AIDS treatment clinical trial within 4 weeks into entry.
- History of significant psychiatric disease.
- History of pancreatitis, history of neuropathy or neurotoxic drug therapy.
- History of serious allergies requiring either systemic steroid therapy or prior hospitalization.
- History of significant arrhythmia, infarction or heart failure. Immunomodulatory therapy such as steroids or cyclosporine, systemic chemotherapy or alpha-interferon.
Prior Medication: Exclusion:
- Past treatment with any protease inhibitor.
- History of neurotoxic drug therapy.
Risk Behavior: Excluded
- Patients with current substance abuse.
- Excessive alcohol intake.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Infections
- Communicable Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Antipyretics
- Antimetabolites
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Protease Inhibitors
- Dermatologic Agents
- Hypnotics and Sedatives
- Anesthetics, Local
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Aldesleukin
- Acetaminophen
- Diphenhydramine
- Promethazine
- Lamivudine
- Zidovudine
- Indinavir
Other Study ID Numbers
- SPIRAT 3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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