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

NCT00000875 | Terminated

• 1 other identifier: SPIRAT 3
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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-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.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; Immunotherapy, Adoptive; T-Lymphocytes, Cytotoxic; Anti-HIV Agents; Viral Load

Interventions

Indinavir sulfate DRUG

Diphenhydramine hydrochloride DRUG

Lymphocytes, Activated DRUG

Lamivudine DRUG

Zidovudine DRUG

Acetaminophen DRUG

Aldesleukin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• Serologically confirmed HIV-1 infection.
• CD4 count \>= 400/mm3.

You may not qualify if:

• 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.
• Past treatment with any protease inhibitor.
• History of neurotoxic drug therapy.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

The Ctr For Blood Research Inc

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; Diphenhydramine; Lymphocyte Count; Lamivudine; Zidovudine; Acetaminophen; aldesleukin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Leukocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine; Acetanilides; Anilides; Amides; Aniline Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: December 14, 2016

Record last verified: 2003-04

Locations

US (1)