Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 antivira...

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ALL

Eligibility criteria

• • 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.