Numerous completed clinical trials spanning Phases 1 through 4 have evaluated zalcitabine for HIV infection and associated comorbidities, including Kaposi sarcoma, hemophilia A, hepatitis C, and progressive multifocal leukoencephalopathy. Sponsored by government institutions like the National Institute of Allergy and Infectious Diseases alongside pharmaceutical companies such as Hoffmann-La Roche, Glaxo Wellcome, and Merck, these studies tested zalcitabine as monotherapy and within combination antiretroviral regimens. Ultimately, these trials aimed to assess the drug's safety, efficacy, and capacity for viral suppression.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT00001040 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
PHASE2 | |
| NCT00000679 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00000678 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00001022 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00002265 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
PHASE2 | |
| NCT00002162 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
PHASE2 | |
| NCT00000625 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00000969 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00002086 | COMPLETED | HIV Infections |
Glaxo Wellcome |
PHASE2 | |
| NCT00002386 | COMPLETED | HIV Infections; Hemophilia A |
Merck Sharp & Dohme LLC |
PHASE4 | |
| NCT00000954 | COMPLETED | Sarcoma, Kaposi; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00000719 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00000997 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00000651 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00000754 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00001035 | COMPLETED | HIV Infections; Hepatitis C |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00000781 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002347 | COMPLETED | HIV Infections |
Parexel |
PHASE2 | |
| NCT00000653 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00001087 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002256 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
||
| NCT00002333 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
PHASE2 | |
| NCT00001048 | COMPLETED | HIV Infections; Leukoencephalopathy, Progressive Multifocal |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002436 | COMPLETED | HIV Infections |
Glaxo Wellcome |
PHASE3 | |
| NCT00002001 | COMPLETED | HIV Infections |
Glaxo Wellcome |
||
| NCT00001032 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002118 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
||
| NCT00002081 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
||
| NCT00000753 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00000682 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00001029 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00000704 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00002109 | COMPLETED | HIV Infections |
Immunobiology Research Institute |
PHASE3 | |
| NCT00002279 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
||
| NCT00000718 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00002334 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
PHASE3 | |
| NCT00000902 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00000978 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00002117 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
PHASE3 |
(data from https://clinicaltrials.gov, updated on 2011-03-01)
Check the
Zalcitabine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.