A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Early immunity to HIV may play an important role in the long interval between virus infection and the onset of clinical disease. Immune responses have been demonstrated in HIV-infected individuals within weeks to months of infection. Although none of these responses has been shown to be protective, it is possible that boosting anti-HIV immune responses through immunization may slow the progression of HIV infection. DTH responses to HIV-derived recombinant envelope glycoprotein could provide a means of measuring an important immune function in infected patients, and serve as an easily measur...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Acute use (\< 14 days) of acyclovir for Herpes simplex virus infections or ketoconazole for symptomatic Candida infections.
• Patients must have the following:
• • Asymptomatic HIV seropositivity.
• • Patients with CD4 counts of 400 - 500 cells/mm3 must be informed of the recommended zidovudine (AZT) therapy and sign an informed consent statement declining AZT therapy.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• * Systemic symptoms other than lymphadenopathy thought to be due to HIV infection including:
• • Fatigue/malaise of \> 1 month duration that interferes with normal activities.
• • Fever of \> 100 degrees F persisting for \> 15 in a 30-day interval without definable cause.
• • Involuntary weight loss in excess of 10 pounds or \> 10 percent of normal weight within a 6-month interval.
• • Diarrhea (\> 3 stools/day) persisting for more than 30 days without definable cause.
• • Recurrent oral candidiasis.
• • Multidermatomal herpes zoster.
• • Biopsy proven hairy leukoplakia.
• • Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
• Concurrent Medication:
• Excluded:
• • Antiretroviral agents of proven or potential efficacy.
• • Any potential immunoenhancing or immunosuppressive drugs.
• Patients with the following are excluded:
• • Known hypersensitivity to insect cells or baculovirus.
• • Abnormal chest x-ray taken within 3 months of study entry.
• • Systemic symptoms other than lymphadenopathy thought to be due to HIV infection as listed in the patient exclusion coexisting diseases or complications.
• • Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
• • Unwilling or unable to give written informed consent.
• Prior Medication:
• Excluded within 90 days of study entry:
• • Zidovudine (AZT).
• • Didanosine (ddI).
• • Any potential antiretroviral.
• • Immunomodulating agents.
• • Active substance abuse (either continuing daily alcohol abuse or intravenous drug use).

Trial Officials