HIV Infections Clinical Trial
Official title:
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.
Status | Terminated |
Enrollment | 16 |
Est. completion date | April 2003 |
Est. primary completion date | April 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Ctr For Blood Research Inc | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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