NCT00002350

Brief Summary

To evaluate safety and immune response in HIV-infected patients treated with multiple injections of APL 400-003 vaccine. PER 2/27/96 AMENDMENT: To evaluate the safety of the vaccine when administered via the Biojector 2000 Needle-Free Injection Management System. Facilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of the genes into host cells. Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies, killer T-cells, and helper T-cells. The safety of this new vaccine approach needs to be assessed. PER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Vaccines, SyntheticAIDS VaccinesDNA, Viral

Interventions

APL 400-003BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Low doses of nonprescription NSAIDS, acetaminophen, ibuprofen, aspirin, replacement hormone therapy, and vitamin supplements.
  • Patients must have:
  • Asymptomatic HIV infection with no acute related infection.
  • CD4 count \>= 500 cells/mm3.
  • Normal hematologic, renal, hepatic, metabolic, and endocrine function.
  • NOTE:
  • No more than one patient over 50 years of age is permitted at each dose level.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Residual toxicity from prior drug treatment.
  • Hypersensitivity to bupivacaine or amide-type local anesthetic.
  • Active viral hepatitis, autoimmune disorders, or other debilitating chronic diseases.
  • Concurrent Medication:
  • Excluded:
  • Medications that affect immune function.
  • Antiretrovirals.
  • Patients with the following prior conditions are excluded:
  • Malignancies other than curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • History of anaphylaxis to vaccines.
  • Prior Medication:
  • Excluded:
  • Prior immunization with any experimental HIV vaccines.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • MacGregor RR, Gluckman S, Lacy K, Kaniefski B, Boyer J, Wang B, Bagarazzi M, William WV, Francher D, Ginsberg R, Higgins T, Weiner D. First human trial of a facilitated DNA plasmid vaccine for HIV-1: safety and host response. Int Conf AIDS. 1996 Jul 7-12;11(2):23 (abstract no WeB293)

    BACKGROUND

  • MacGregor R, Gluckman S, Lacy K, Wang B, Ugen K, Chattergoon M, Bagarazzi J, Williams W, Ginsberg R, Higgins T, Boyer J, Weiner D. A DNA plasmid vaccine for HIV-1: experience in the first human trial indicates humoral and cell-immune responses. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:142 (abstract no 421)

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-07

Locations

US(1)