Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 evaluate stavudine primarily for HIV infection, acquired immune deficiency syndrome, AIDS dementia complex, and complications such as cryptococcal meningitis and hepatitis C. Sponsored by academic institutes, public research organizations, and pharmaceutical companies, these studies exhibit statuses ranging from completed to terminated, withdrawn, suspended, or unknown. Across these protocols, key investigated outcomes include long-term treatment parameters, epidermal nerve density, and steady-state pharmacokinetics.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00074581 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-02 PHASE3
NCT01146873 COMPLETED
HIV/AIDS; HIV Infections
Columbia University
 2010-07 PHASE3
NCT02670772 COMPLETED
Acquired Immune Deficiency Syndrome; Human Immunodeficiency Virus
Willem Daniel Francois Venter
 2012-07 PHASE3
NCT01694017 COMPLETED
HIV
Tufts University
 2012-11 PHASE4
NCT00986063 COMPLETED
Nevirapine Induced Rash; Nevirapine Induced Hepatitis; HIV; Adverse Side Effects; AIDS; HIV Infections
Surakameth Mahasirimongkol
 2009-07 PHASE4
NCT01344148 UNKNOWN
AIDS
Shanghai Public Health Clinical Center
 2009-02
NCT00669487 COMPLETED
HIV Infections
SEARCH Research Foundation
 2008-04 PHASE3
NCT01601899 TERMINATED
Mitochondrial Toxicity; Metabolic Complications
University of Witwatersrand, South Africa
 2008-10 PHASE4
NCT01178684 Completed
HIV
SEARCH Research Foundation|University of Hawaii
 2010-05 --
NCT00100646 COMPLETED
HIV Infections
The Wistar Institute
 2007-03
NCT00703898 COMPLETED
HIV Infections
Bamrasnaradura Infectious Diseases Institute
 2004-11 PHASE4
NCT00872417 UNKNOWN
Acquired Immune Deficiency Syndrome; HIV Infections
Peking Union Medical College
 2009-03 PHASE4
NCT00039741 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-08 PHASE2; PHASE3
NCT00427297 TERMINATED
HIV Infections
University of Washington
 2007-09 PHASE3
NCT00528957 COMPLETED
HIV Infections
Gilead Sciences
 2006-12-28 PHASE3
NCT00380770 COMPLETED
HIV; AIDS; Kaposi's Sarcoma; Human Herpesvirus 8
University of KwaZulu
 2003-01 PHASE4
NCT00255840 COMPLETED
HIV Infections
CIPRA SA
 2006-07
NCT00830856 COMPLETED
Cryptococcal Meningitis; HIV Infections
University of Zimbabwe
 2006-10
NCT00312091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-12 PHASE1; PHASE2
NCT00342355 COMPLETED
HIV
National Institutes of Health Clinical Center (CC)
 2004-01 PHASE4
NCT00455585 COMPLETED
HIV Infections
Makerere University
 2007-01 PHASE4
NCT00455585 Completed
HIV Infections
Makerere University|Department of Foreign Affairs Ireland
 2007-01 Phase 4
NCT00192660 COMPLETED
HIV-Associated Lipodystrophy Syndrome; Cardiovascular Disease
Kirby Institute
 2003-02 PHASE4
NCT00618176 COMPLETED
HIV Infections
Peking Union Medical College
 2005-01 PHASE4
NCT00055120 COMPLETED
HIV Infections; AIDS-Related Opportunistic Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2003-03 PHASE4
NCT00143702 COMPLETED
Acidosis, Lactic
University of British Columbia
 2001-08 PHASE2; PHASE3
NCT01025830 COMPLETED
HIV/AIDS
Makerere University
 2006-02 PHASE4
NCT00135369 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2002-09 PHASE3
NCT00116116 COMPLETED
HIV Infections; AIDS
Bristol-Myers Squibb
 2002-03 PHASE4
NCT00004578 COMPLETED
HIV Infections
Abbott
 1997-11 PHASE1; PHASE2
NCT00116298 COMPLETED
HIV Infections; AIDS
Bristol-Myers Squibb
 2001-01 PHASE3
NCT00014937 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00647946 COMPLETED
Lipodystrophy
Gilead Sciences
 2003-02 PHASE2
NCT00235222 Unknown status
HIV
Groupe Hospitalier Pitie-Salpetriere|Bristol-Myers Squibb
 2004-06 Phase 4
NCT00002207 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2004-02
NCT00006443 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001122 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000922 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00005918 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2000-06 PHASE3
NCT00116116 Completed
HIV Infections|AIDS
Bristol-Myers Squibb
 2002-03 Phase 4
NCT00002240 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1999-03 PHASE2
NCT00158821 COMPLETED
HIV Infections
Gilead Sciences
 2000-03 PHASE3
NCT00002429 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1999-07 PHASE3
NCT02249130 COMPLETED
HIV Infections
Boehringer Ingelheim
 1999-03 PHASE2
NCT00002177 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1997-05
NCT00002176 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1997-05
NCT00002411 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1998-03
NCT00002349 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1995-01
NCT00000882 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002224 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1999-03 PHASE3
NCT00002246 COMPLETED
AIDS Dementia Complex; HIV Infections
Bristol-Myers Squibb
 1997-10 PHASE3
NCT00002371 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1996-06 PHASE3
NCT00000870 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002225 COMPLETED
HIV Infections
Dupont Merck
 PHASE2
NCT00002208 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE3
NCT00001083 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00004583 COMPLETED
HIV Infections
Abbott
 1999-03 PHASE3
NCT00002386 COMPLETED
HIV Infections; Hemophilia A
Merck Sharp & Dohme LLC
 PHASE4
NCT00000841 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00080522 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-02
NCT00002374 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00002369 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00002451 UNKNOWN
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00001067 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002442 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-06 PHASE2
NCT00000896 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001095 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00017992 UNKNOWN
HIV Infections
Triangle Pharmaceuticals
 PHASE2
NCT00002241 UNKNOWN
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00000924 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000916 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00036452 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000899 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000939 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000822 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000919 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00006144 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2000-10 PHASE2
NCT00001108 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000865 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002230 COMPLETED
HIV Infections
Northwestern University
 PHASE3
NCT00000686 TERMINATED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00006208 UNKNOWN
HIV Infections
Triangle Pharmaceuticals
 2000-08 PHASE3
NCT00312832 COMPLETED
HIV Infections; Lipoatrophy
Hospital Clinic of Barcelona
 2004-01
NCT00001087 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00007202 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00006190 COMPLETED
HIV Infections; Lipodystrophy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2000-11 PHASE4
NCT00002308 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00002418 TERMINATED
HIV Infections
Bristol-Myers Squibb
 PHASE2
NCT00000831 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00013520 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00006339 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00001688 COMPLETED
HIV Infection
National Cancer Institute (NCI)
 1998-01 PHASE2
NCT00001818 COMPLETED
HIV Infection
National Cancer Institute (NCI)
 1999-06 PHASE1
NCT00270556 COMPLETED
HIV
Gilead Sciences
 2003-01 PHASE2
NCT00002379 COMPLETED
HIV Infections
Gilead Sciences
 PHASE2
NCT00002378 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00000885 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002381 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE1
NCT00000789 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000901 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00034086 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00006154 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00005000 UNKNOWN
HIV Infections
Agouron Pharmaceuticals
 1999-12 PHASE4
NCT00002307 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00235222 UNKNOWN
HIV
Groupe Hospitalier Pitie-Salpetriere
 2004-06 PHASE4
NCT00002416 COMPLETED
HIV Infections
Triangle Pharmaceuticals
 PHASE3
NCT00197613 COMPLETED
AIDS; HIV Infection
Harvard School of Public Health (HSPH)
 2002-12 PHASE3
NCT00004855 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00006397 UNKNOWN
HIV Infections
PPD Development, LP
 2000-08 PHASE3
NCT00000872 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002211 COMPLETED
HIV Infections
Pharmacia and Upjohn
NCT00000878 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00005017 UNKNOWN
HIV Infections
Glaxo Wellcome
 PHASE4
NCT00000918 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002227 COMPLETED
HIV Infections
Dupont Merck
 PHASE2
NCT00002362 SUSPENDED
HIV Infections
Triangle Pharmaceuticals
 1999-08 PHASE3
NCT00004736 COMPLETED
HIV Infections; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002109 COMPLETED
HIV Infections
Immunobiology Research Institute
 PHASE3
NCT00002424 SUSPENDED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00000851 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002412 COMPLETED
HIV Infections
Triangle Pharmaceuticals
 PHASE2
NCT00000988 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000923 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002407 COMPLETED
HIV Infections
Weill Medical College of Cornell University
NCT00000838 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00001084 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000902 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002168 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00050895 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00002420 TERMINATED
HIV Infections
Bristol-Myers Squibb
 PHASE2
NCT00001063 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002430 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00002397 COMPLETED
HIV Infections; AIDS-Associated Nephropathy
Hoffmann-La Roche
 PHASE3
NCT00005106 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-09 PHASE4
NCT00002171 COMPLETED
HIV Infections
Agouron Pharmaceuticals
 PHASE2
NCT00005018 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-07 PHASE4
NCT00002354 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00002427 COMPLETED
HIV Infections
Research Institute for Genetic and Human Therapy
 1999-05 PHASE1
NCT00127972 COMPLETED
HIV Infections
International Antiviral Therapy Evaluation Center
 2004-02 PHASE4
NCT00002184 COMPLETED
HIV Infections
Gilead Sciences
 PHASE2
NCT00002162 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE2
NCT00002376 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE4
NCT00001091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000940 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 1999-05 PHASE2
NCT00000891 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2

(data from https://clinicaltrials.gov, updated on 2021-11-05)

Check the d4T (Stavudine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Stavudine is a thymidine analog that undergoes intracellular phosphorylation into its active triphosphate form, which competitively inhibits HIV reverse transcriptase and incorporates into viral DNA to cause premature chain termination. By halting viral DNA synthesis and preventing viral replication, stavudine reduces systemic viral load to manage human immunodeficiency virus infections and acquired immune deficiency syndrome.

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>).

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Note: Technical data last updated: Sep 1, 2026.