The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease
2 other identifiers
interventional
N/A
3 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
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5 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
September 1, 1991
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- 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.
- +46 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (5)
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Georgetown Univ Med Ctr / Main Hosp 4
Washington D.C., District of Columbia, 20007, United States
Vanderbilt School of Medicine
Nashville, Tennessee, 37232, United States
Saint Vincent's Hosp Med Centre
Darlinghurst, Australia
San Juan Veterans Administration Med Ctr
San Juan, 009275800, Puerto Rico
Related Publications (1)
Larder BA, Kohli A, Bloor S, Kemp SD, Harrigan PR, Schooley RT, Lange JM, Pennington KN, St Clair MH. Human immunodeficiency virus type 1 drug susceptibility during zidovudine (AZT) monotherapy compared with AZT plus 2',3'-dideoxyinosine or AZT plus 2',3'-dideoxycytidine combination therapy. The protocol 34,225-02 Collaborative Group. J Virol. 1996 Sep;70(9):5922-9. doi: 10.1128/JVI.70.9.5922-5929.1996.
PMID: 8709213BACKGROUND