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Zalcitabine

Phase 4

HIV Infections | Small molecule | Infectious Disease |Roche Holding AG|Trials Updated: Jun 24, 2005

Zalcitabine development status

Highest phase Phase 4 run by Merck Sharp & Dohme LLC (NCT00002386)
Phase scored for RHHBYPhase 3
Registered trials 34 across 3 sponsors since Aug 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment528

FDA Designations

No designations recorded

Zalcitabine clinical trials

Zalcitabine · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00002117A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV InfectionHIV Infections
COMPLETED528 Analytics
PHASE3COMPLETED
A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection
HIV InfectionsUnlock trial analytics

Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
ZidovudineDRUG -
ZalcitabineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria Patients must have: * HIV infection. * CD4 count 100 - 500 cells/mm3.

Countries:United States
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Frequently asked questions about Zalcitabine

What is Zalcitabine used for?

Zalcitabine is an investigational small molecule studied for the treatment of HIV Infections. It was evaluated in clinical trials both as a single agent and in combination regimens with zidovudine (AZT), including in patients with AIDS or advanced ARC who had previously shown intolerance to zidovudine.

Who makes Zalcitabine?

Zalcitabine was developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the clinical trial program evaluating the drug in HIV Infections, including studies of Zalcitabine alone and in combination with zidovudine.

What phase is Zalcitabine in?

Zalcitabine reached Phase 3 clinical development for HIV Infections. Its Phase 3 trial, NCT00002117, was a randomized, open-label study of alternative treatment combinations of dideoxycytidine (ddC) and zidovudine (AZT) in patients with HIV infection. Zalcitabine is investigational and is not an approved therapy based on this development record.

What clinical trials is Zalcitabine in?

Zalcitabine was studied in two completed HIV Infection trials. NCT00002117 was a Phase 3 randomized, open-label study of ddC and AZT combinations with 528 patients. NCT00002265 was a Phase 2 open-label, multicenter study of dideoxycytidine in patients with AIDS or advanced ARC who were intolerant to zidovudine.

Is Zalcitabine the same as ddC or HIVID?

Yes. Zalcitabine is also known as dideoxycytidine, abbreviated ddC, and was marketed under the brand name HIVID. These names refer to the same small molecule, which was studied in HIV Infections both as monotherapy and in combination with zidovudine (AZT).

How many patients were enrolled in Zalcitabine trials?

The Zalcitabine clinical program enrolled 528 patients in total, all in the Phase 3 trial NCT00002117, which compared alternative combinations of dideoxycytidine (ddC) and zidovudine (AZT) in patients with HIV infection. The Phase 2 study NCT00002265 did not report an enrollment figure.