Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00000875 |
|
Recruitment Status :
Terminated
First Posted : August 31, 2001
Last Update Posted : December 14, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Indinavir sulfate Drug: Diphenhydramine hydrochloride Drug: Lymphocytes, Activated Drug: Lamivudine Drug: Zidovudine Drug: Acetaminophen Drug: Aldesleukin | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 16 participants |
| Intervention Model: | Parallel Assignment |
| Primary Purpose: | Treatment |
| Official Title: | Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection |
| Actual Primary Completion Date : | April 2003 |
| Actual Study Completion Date : | April 2003 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000875
| United States, Massachusetts | |
| The Ctr For Blood Research Inc | |
| Boston, Massachusetts, United States, 02115 | |
| ClinicalTrials.gov Identifier: | NCT00000875 History of Changes |
| Other Study ID Numbers: |
SPIRAT 3 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | December 14, 2016 |
| Last Verified: | April 2003 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Drug Therapy, Combination Immunotherapy, Adoptive T-Lymphocytes, Cytotoxic Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
|
Infection Communicable Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Acetaminophen Diphenhydramine Lamivudine Zidovudine |
Aldesleukin Indinavir Antiviral Agents Promethazine Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |