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

• Status: Terminated
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Acetaminophen; Aldesleukin; Antiviral Agents; Diphenhydramine; Indinavir; Lamivudine; Promethazine; Zidovudine

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.