Clinical trial NCT00002020: Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC
Official title: Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Univ of Arizona / Health Science Ctr
state: Arizona
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Cook County Hosp
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Kansas City
country: United States
facility: Univ of Missouri at Kansas City School of Medicine
state: Missouri
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: Albuquerque
country: United States
facility: Univ of New Mexico Hlth Sciences Ctr / Dept of Med
state: New Mexico
city: Manhasset
country: United States
facility: Northshore Hosp / Cornell Univ
state: New York
city: Philadelphia
country: United States
facility: Univ of Pennsylvania / HIV Clinic
state: Pennsylvania
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Juan
country: Puerto Rico
facility: San Juan Veterans Administration Med Ctr
Study officials:
References: