NCT00001992

Brief Summary

To test the safety and immunogenicity of rgp 120/HIV-1IIIB vaccine in HIV-1 seropositive adult patients.

Trial Health

80
On Track

Trial Health Score

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

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

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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

August 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Vaccines, SyntheticDrug EvaluationAcquired Immunodeficiency SyndromeAIDS Vaccines

Interventions

rgp120/HIV-1IIIBBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Patients must have the following:
  • Stage 1 or 2 Walter Reed clinical staging of HIV infected individuals.
  • The ability to understand and sign a written informed consent form, which must be obtained prior to study entry.
  • Be available for 24 weeks so that follow up may be completed.
  • Qualify for care as Department of Defense health care beneficiary.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Prior history of clinically significant cardiac, pulmonary, hepatic, renal, neurologic or autoimmune disease, other than HIV-1 infection, and in less than average general health as determined by a medical history, physical examination, and the required laboratory test results.
  • Concurrent Medication:
  • Excluded:
  • Corticosteroids or other known immunosuppressive drugs.
  • Any experimental agents.
  • Patients with the following are excluded:
  • Prior history of clinically significant cardiac, pulmonary, hepatic, renal, neurologic or autoimmune disease, other than HIV-1 infection, and in less than average general health as determined by a medical history, physical examination, and the required laboratory test results.
  • Prior Medication:
  • Excluded within 30 days of study entry:
  • Zidovudine or other anti-retroviral agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-08

Locations

US(1)