Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000977
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
• Scientific title: Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
• Date of first enrolment: November 1999
• Target sample size: 52
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000977
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Valentine F

Key inclusion & exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Acute use (< 14 days) of acyclovir for Herpes simplex virus infection or ketoconazole
for symptomatic Candida infections.

An additional group of up to 20 patients may be added to the study. Patients from ACTG 148
with a repeatedly negative delayed-type hypersensitivity (DTH) reaction who have reached
their third dose of ID gp160 at 32 mcg and have failed to develop new proliferative
response have the option, after a 2-month interval, to enter this protocol.

- They must meet inclusion and exclusion criteria that apply to this protocol.

- 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:

- Fever of > 100 degrees F persisting for > 15 days in a 30-day interval without
definable cause.

- Recurrent oral candidiasis.

- Multidermatomal herpes zoster.

- Biopsy-proven hairy leukoplakia.

- Fatigue/malaise of > 1 month duration that interferes with normal activities.

- Evidence of clinically significant central nervous system dysfunction as assessed by
neurological exam.

- Involuntary weight loss > 10 lbs or 10 percent of normal weight in a 6 month
interval.

- Diarrhea (> 3 stools/day) for more than 30 days without definable cause.

Concurrent Medication:

Excluded:

- Antiretroviral agents of proven or potential efficacy or 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 thought to be due to HIV infection (other than lymphadenopathy).
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), or any potential antiretroviral or
immunomodulating agents.

Active substance abuse (either continuing daily alcohol abuse or intravenous drug use).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Biological: gp160 Vaccine (MicroGeneSys)

Secondary ID(s)

11112

ACTG 137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Protein Sciences Corporation