The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety and the tolerance of the coadministration of zidovudine and ddI or ddC.

Key facts

Study ID

NCT00002001

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Patients with PCP may be randomized to study medication after contacting the sponsor and following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 C for at least 48 hours, p02 (on room air) > or = 60 mm and an A/A gradient < or = 30 mm.
• Prophylaxis for PCP.
• Patients must have the following:
• HIV-1 seropositive by any federally licensed ELISA.
• Willingness to give informed consent.

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Any immediately life-threatening infection or medical condition present at time of study entry.
• Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section.
• Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix.
• Kaposi's sarcoma with visceral involvement or requiring systemic cytotoxic chemotherapy.
• AIDS dementia complex, > or = Stage 2.
• History of zidovudine induced toxicity.
• Prior history of acute pancreatitis during the past two years or chronic pancreatitis.
• Grade 2 neuropathy.
• Intractable diarrhea.
• History of seizures within the past six months or current requirement of anticonvulsants.
• Past or current heart disease.
• Fever > 39 C at entry.
• Concurrent Medication:
• Current requirement of anticonvulsants.
• Excluded:
• It is intended that patients developing new opportunistic infections during the course of the study will continue study participation, unless required therapy is associated with significant neurologic or hematologic toxicities, in which case the study medication may be temporarily discontinued.
• Ganciclovir.
• Chloramphenicol.
• Cisplatinum.
• Iodoquinol.
• Systemic Pentamidine.
• Disulfiram.
• Ethionamide.

Where it is running

• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Georgetown Univ Med Ctr / Main Hosp 4 — Washington D.C., District of Columbia, United States
• Vanderbilt School of Medicine — Nashville, Tennessee, United States
• Saint Vincent's Hosp Med Centre — Darlinghurst, Australia
• San Juan Veterans Administration Med Ctr — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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