Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002020

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

To evaluate the safety and tolerance, in patients with severe clinical manifestations of HIV infection, of zidovudine (AZT) administered daily for 48 weeks as a low dose every 4 hours or a higher dose every 12 hours.

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

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Medication:

Allowed:

Prophylaxis or treatment for Pneumocystis carinii pneumonia (PCP) consisting of either trimethoprim / sulfamethoxazole, aerosolized pentamidine, pyrimethamine / sulfadoxine, or dapsone allowed at the discretion of the investigator.

Patients with the following are excluded:

Any immediately life-threatening infection or medical condition present at the time of study entry.
Any active opportunistic or other infection requiring chronic therapy at the time of study entry. Patients with PCP may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have a fever < 39 C for at least 48 hours, pO2 (on room air ) = or > 60 mm, and an Arterial/alveolar gradient = or < 30 mm.
Diagnosis of AIDS Dementia Complex.
Received more than 4 weeks of antiretroviral therapy or who previously discontinued antiretroviral therapy due to drug related toxicity.
Diseases and conditions listed in Exclusion Co-existing Conditions.

Patients must have the following:

Seropositive for HIV infection documented by any federally licensed ELISA and confirmed by Western blot.
Advanced HIV disease or AIDS-related complex.
Ability to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

AIDS with malignant disease likely to require cytotoxic chemotherapy.
Diagnosis of AIDS Dementia Complex.
Impaired renal function ( Creatinine clearance < 50 ml/min/1.73m2 or serum creatinine = or > 2 mg/dl).
Impaired hepatic function ( ALT = or > 5 x upper limit of normal).
Fever > 39 C at entry.

Concurrent Medication:

Excluded:

Any other experimental therapy.
Drugs which cause significant bone marrow suppression.
Cytolytic chemotherapy.
Drugs which cause significant nephrotoxicity or hepatotoxicity.

Concurrent Treatment:

Excluded:

Radiation therapy (with the exception of electron beam therapy to an area < 100 cm2).

Prior Medication:

Excluded within 2 weeks of study entry:

Any other experimental therapy. Drugs which cause significant bone marrow suppression. Cytolytic chemotherapy. Drugs which cause significant nephrotoxicity or hepatotoxicity.

Excluded within 4 weeks of entry:

Immunomodulating agents, including pharmacological doses of steroids for more than 10 days (except for management of severe PCP in which case duration should not exceed 21 days). Interferon. Isoprinosine. IL-2.

Excluded within 8 weeks of entry:

Antiretroviral agents including:

Ribavirin. Dideoxycytidine (ddC). Dideoxyadenosine (ddA). Didanosine (ddI). Foscarnet. Dextran Sulfate. AL-721. Retrovir (Zidovudine, AZT) for greater than 4 weeks or within 90 days of study entry, or patients who originally discontinued Retrovir due to drug-related toxicity. Drugs metabolized by hepatic glucuronidation may alter the metabolism of Retrovir and should not be used chronically.

Prior Treatment:

Excluded:

Radiation therapy (with the exception of electron beam therapy to an area < 100 cm2) within 2 weeks of study entry.

Known active drug or alcohol abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Arizona / Health Science Ctr	Tucson	Arizona	United States	85724
2	Northwestern Univ Med School	Chicago	Illinois	United States	60611
3	Cook County Hosp	Chicago	Illinois	United States	60612
4	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
5	Univ of Missouri at Kansas City School of Medicine	Kansas City	Missouri	United States	64108
6	North Jersey Community Research Initiative	Newark	New Jersey	United States	071032842
7	Univ of New Mexico Hlth Sciences Ctr / Dept of Med	Albuquerque	New Mexico	United States	87131
8	Northshore Hosp / Cornell Univ	Manhasset	New York	United States	11030
9	Univ of Pennsylvania / HIV Clinic	Philadelphia	Pennsylvania	United States	19104
10	Univ TX Galveston Med Branch	Galveston	Texas	United States	77550
11	Baylor College of Medicine	Houston	Texas	United States	77030
12	San Juan Veterans Administration Med Ctr	San Juan		Puerto Rico	009275800