Overview

A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS dementia complex and to assess the safety and tolerance of the treatment regimens.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Glaxo Wellcome
Treatments:
Abacavir
Criteria
Inclusion Criteria

Patients must have:

- Documented HIV infection.

- Evidence of HIV - associated dementia.

- Been on stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

- Debilitated as a result of their HIV disease, associated illness or therapies who the
investigator determines will not be able to complete the 12 week randomized dosing
period.

- Memorial Sloan-Kettering (MSK) score of >= 3 for dementia.

- Confounding neurological diseases which may interfere with interpretation of
neurological and neurophysical assessments.

- Malabsorption syndrome or other gastrointestinal dysfunction which renders them unable
to take oral medication.

- Chronic diseases such as diabetes, congestive heart failure, cardiomyopathy, other
cardiac dysfunctions, etc., which in the investigator's opinion would compromise the
safety of the patient.

- Symptomatic AIDS-defining opportunistic infection not responsive to therapy.

Concurrent Medication:

Excluded:

- Treatment with cytotoxic chemotherapeutic agents within the first 12 weeks of the
study.

- Treatment with nerve growth factor within the first 12 weeks of study.

- The use of narcotic analgesics, sedatives, benzodiazepines, antidepressants,
anti-psychotic agents and other psychoactive drugs which would interfere with the
assessment of the neurological and neurophysical status of the patient.

- Use of stavudine (d4T) during the first 12 weeks of the study.

- Immunomodulating agents (except GM/G-CSF or epoietin).

- Psychoactive drugs (at the investigator's discretion).

Concurrent Treatment:

Excluded:

- Treatment with radiation therapy within the first 12 weeks of the study.

NOTE:

- With the exception of local treatment for Kaposi's sarcoma.

Patients with any of the following prior conditions are excluded:

- Previous neurological disease unrelated to HIV infection.

- History of clinically apparent hepatitis within the last 6 months.

- History of clinically apparent pancreatitis in the last 6 months.

Prior Medication:

Excluded:

- Treatment with cytotoxic chemotherapeutic agents within 1 month of entry.

- Participation in investigational antiretroviral trials within the past 3 months.

- HIV vaccine within the past 3 months.

- Treatment with immunomodulating agents such as systemic corticosteroids, interleukins,
thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study
entry.

- Nerve growth factor.

Prior Treatment:

Excluded:

- Treatment with radiation therapy within 1 month of entry.

NOTE:

- With the exception of local treatment for Kaposi's sarcoma.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use which may interfere with the patient's ability to
comply with the study protocol.

Required:

- Stable antiretroviral treatment that has been ongoing for a minimum of 6 weeks prior
to study entry, may or may not include ZDV.

Required:

- Stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.