Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.16 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The Ctr For Blood Research Inc
Boston, United StatesOpen The Ctr For Blood Research Inc in Google Maps