Status:
COMPLETED
A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Bristol-Myers Squibb
Immuno-US
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific ant...
Detailed Description
HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression. Patients w...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- ddI [AS PER AMENDMENT 11/12/96: and d4T]. (Note:
- Patients in the stratum receiving only vaccine or control may take ddI [AS PER AMENDMENT 11/12/96:
- and d4T] ONLY IF their CD4 counts have shown a sustained decrease on two consecutive occasions 10-14 days apart.)
- PCP prophylaxis.
- Treatment for acute conditions, as indicated.
AS PER AMENDMENT 11/12/96:
- Co-enrollment on other research trials.
Patients must have:
- HIV positivity.
- Asymptomatic disease.
- CD4 count >= 50 cells/mm3 (CD4 count must be 50-499 cells/mm3 in patients receiving ddI plus vaccine or control, and must be >= 500 cells/mm3 in patients receiving vaccine or control only)
[AS PER AMENDMENT 11/12/96:
- CD4 count >= 500 cells/mm3 for stratum 1 patients and 200-400 for stratum 2 patients].
- HLA A2 positive documentation.
- An Epstein Barr virus B cell line established within 90 days prior to study entry.
- Consent of parent or guardian if less than 18 years of age.
NOTE:
- Study is NOT approved for prisoner participation.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Medical contraindication to study participation or inability to comply with study requirements.
- Grade 2 or worse peripheral neuropathy (applicable only to patients receiving ddI plus vaccine or control).
Concurrent Medication:
Excluded:
- Immunomodulating agents, such as inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids.
- Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine [AS PER AMENDMENT 11/12/96:
- e.g., zalcitabine or lamivudine]).
- Agents such as IV pentamidine that may increase the risk of pancreatitis.
- Standard of care vaccines (in patients receiving vaccine) [AS PER AMENDMENT 11/12/96:
- Standard of care immunizations are permitted 60 days before Schedule 1 vaccine therapy and during Schedule 2 vaccine therapy (but not within 2 weeks of study immunization)].
AS PER AMENDMENT 11/12/96:
-
Rifabutin, disulfiram (antabuse), or other medication with similar effects, including metronidazole.
6.AS PER AMENDMENT 11/12/96:
-
The following are prohibited in patients receiving ritonavir:
-
amiodarone, astemizole, bepridil, bupropion, cisapride, clozapine, encainide, flecainide, meperidine, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, terfenadine, alprazolam, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam, and zolpidem.
Patients with the following prior conditions are excluded:
- History of grade 2 or worse liver abnormality.
- Known allergy to vaccine components.
- Chronic diarrhea persisting for 4 or more weeks within 30 days prior to study entry.
- History of pancreatitis (applicable only to patients receiving ddI plus vaccine or control). [AS PER AMENDMENT 11/12/96:
- History of chronic pancreatitis or history of acute pancreatitis within 2 years prior to entry (stratum 2 patients only).]
Prior Medication:
Excluded:
- Any prior anti-HIV vaccines.
Excluded within 90 days prior to study entry:
- Immunomodulating agents, such as Inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids.
- Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine [AS PER AMENDMENT 11/12/96:
- e.g., zalcitabine or lamivudine]).
- Agents such as IV pentamidine that may increase the risk of pancreatitis.
- Any treatment for an AIDS-defining illness (applicable ONLY to patients in the stratum receiving ddI plus vaccine or control).
Excluded within 6 months prior to study entry:
- Any other antiretrovirals or immunomodulators besides those mentioned above.
- Allergy desensitization or other vaccines [AS
PER AMENDMENT 11/12/96:
- excluded within 60 days prior to entry].
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 1999
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00000822
End Date
May 1 1999
Last Update
October 29 2021
Active Locations (1)
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1
Stanford CRS
Stanford, California, United States, 943055107