A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
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|ClinicalTrials.gov Identifier: NCT00000625|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : April 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine||Phase 2|
Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm.
PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2100 participants|
|Official Title:||A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3|
|Actual Study Completion Date :||November 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000625
Show 58 Study Locations
|Study Chair:||Katzenstein D|
|Study Chair:||Hammer S|