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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002163
Other study ID # 238B
Secondary ID CNAB 3001
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date November 1998
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

Patients must be on stable antiretroviral treatment for at least 6 weeks prior to study entry and will then be stratified depending on whether their regimen contains zidovudine (ZDV). Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For the subsequent 40 weeks, open-label 1592U89 will be offered.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Abacavir sulfate


Locations

Country Name City State
Canada Wellesley Hosp Toronto Ontario
Canada Univ of Manitoba / Faculty of Medicine Winnipeg Manitoba
United States Johns Hopkins Univ School of Medicine Baltimore Maryland
United States Univ of North Carolina School of Medicine Chapel Hill North Carolina
United States Columbia Univ / Sergievsky Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States HIV Neurobehavioral Research Ctr San Diego California
United States San Francisco Gen Hosp San Francisco California
United States Washington Univ Med Ctr St Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Lanier ER, Sturge G, McClernon D, Brown S, Halman M, Sacktor N, McArthur J, Atkinson JH, Clifford D, Price RW, Simpson D, Torres G, Catalan J, Marder K, Power C, Hall C, Romero C, Brew B. HIV-1 reverse transcriptase sequence in plasma and cerebrospinal fluid of patients with AIDS dementia complex treated with Abacavir. AIDS. 2001 Apr 13;15(6):747-51. — View Citation

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