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A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rgp120/HIV-1IIIB
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS Vaccines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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.

Sites / Locations

  • Walter Reed Army Institute of Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00001992
Brief Title
A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers
Official Title
A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 1992
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1IIIB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Facility Information:
Facility Name
Walter Reed Army Institute of Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers

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