A Prospective Double-Blind Study of Retrovir in Early HIV Infection

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002045

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.

(12/01/89) Information supplied by drug company update. Study discontinued due to positive data from ACTG 016.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Zidovudine	N/A

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Prospective Double-Blind Study of Retrovir in Early HIV Infection

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Treatment:

Allowed:

Electron beam therapy to an area of less than 100 cm2.

Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis).

Patient must be able to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse.
Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria.
Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
Evidence of compromised bone marrow function defined by specified lab values.
Evidence of HIV neurologic disease.
Evidence of HIV-associated "wasting syndrome".
Hypersensitivity to zidovudine (AZT).

Concurrent Medication:

Excluded:

Cytotoxic chemotherapeutic agents.
Steroids.
Interferon or immunomodulating agents.
Any antiretroviral drug including, but not limited to zidovudine (AZT), ribavirin, HPA23, AL 721, or phosphonoformate.

Patients with the following are excluded:

Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
Evidence of compromised bone marrow function defined by specified lab values. Evidence of HIV neurologic disease.
Evidence of HIV-associated wasting syndrome.
Hypersensitivity to retrovir.