Status:
TERMINATED
Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 ...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00000875
End Date
April 1 2003
Last Update
December 14 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ctr For Blood Research Inc
Boston, Massachusetts, United States, 02115