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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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rgp120/HIV-1IIIB

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Walter Reed Army Institute of Research

Rockville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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V0200g

Identifier Type: -

Identifier Source: secondary_id

075A