Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Diphenhydramine hydrochloride (Drug); Lymphocytes, Activated (Drug); Lamivudine (Drug); Zidovudine (Drug); Acetaminophen (Drug); Aldesleukin (Drug)
Phase: N/A
Status: Terminated
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Clinical Details
Official title: Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection
Study design: Treatment, Parallel Assignment, Safety Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
The Ctr For Blood Research Inc, Boston, Massachusetts 02115, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Aldesleukin Click here for more information about Lamivudine Click here for more information about Indinavir sulfate
Last updated: June 23, 2005
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