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
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Injections, Intradermal, HIV Antigens, HIV Seropositivity, HIV-1, Drug Evaluation, Hypersensitivity, Delayed, AIDS Vaccines, HIV Therapeutic Vaccine
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).
Sites / Locations
- NY Univ. HIV/AIDS CRS