Clinical Trials

Abacavir sulfate has been evaluated in numerous clinical trials spanning early phase 1 through phase 4, as well as bioequivalence research in healthy subjects, primarily focusing on HIV-1 infection along with secondary conditions such as endothelial dysfunction and HIV-associated lipodystrophy. Sponsored by pharmaceutical developers—including GlaxoSmithKline, ViiV Healthcare, Glaxo Wellcome, and Mylan—and public or academic institutions such as NIAID and the Kirby Institute, the majority of these registered studies are completed. However, overall trial statuses vary across records, ranging from actively recruiting to terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07792096 NOT_YET_RECRUITING
HIV Infection
University College, London
 2026-11 PHASE3
NCT06428045 RECRUITING
High Grade Glioma
University of Miami
 2025-04-15 PHASE1
NCT06356740 NOT_YET_RECRUITING
Systemic Lupus Erythematosus
Hospices Civils de Lyon
 2024-09-01 PHASE2
NCT05193994 TERMINATED
Amyotrophic Lateral Sclerosis
Macquarie University, Australia
 2022-02-24 PHASE3
NCT06658977 TERMINATED
Amyotrophic Lateral Sclerosis; ALS
Macquarie University, Australia
 2024-11-15 PHASE3
NCT04731103 COMPLETED
Aicardi-Goutières Syndrome
University of Edinburgh
 2022-08-24 PHASE2
NCT04904406 COMPLETED
Hiv; HIV Infections; HIV Cardiomyopathy; Weight Change, Body; HIV Lipodystrophy; Cardiovascular Diseases
Thomas Benfield
 2020-10-22 PHASE4
NCT00799864 COMPLETED
HIV-1
Janssen Sciences Ireland UC
 2011-01 PHASE2
NCT03760458 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2020-09-09 PHASE1; PHASE2
NCT02659761 TERMINATED
Human Immunodeficiency Virus
University College Dublin
 2016-11 PHASE4
NCT05030025 COMPLETED
HIV-1-infection
Mylan Inc.
 2021-08-01 EARLY_PHASE1
NCT04827134 COMPLETED
HIV Infections
ViiV Healthcare
 2021-05-07 PHASE1
NCT04155554 UNKNOWN
HIV-1-infection
Azienda Ospedaliera Universitaria Senese
 2020-01-29 PHASE3
NCT03685500 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2018-12-04 PHASE4
NCT02957864 UNKNOWN
Renal Insufficiency,Chronic; Hiv; Therapeutic Agent Toxicity
Erasmus Medical Center
 2016-10 PHASE4
NCT03360682 COMPLETED
HIV-1-infection; Solid Organ Transplant
Fundacion Clinic per a la Recerca Biomédica
 2018-04-13 PHASE4
NCT02384395 COMPLETED
HIV; Acute HIV Infection
University of North Carolina, Chapel Hill
 2015-09
NCT04133012 Completed
HIV-1 Infection
ANRS Emerging Infectious Diseases|ViiV Healthcare
 2020-02-10 Not Applicable
NCT03836833 UNKNOWN
HIV
Drugs for Neglected Diseases
 2019-06-04 PHASE1; PHASE2
NCT03067285 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2017-09-08 PHASE4
NCT02363452 COMPLETED
Aicardi-Goutières Syndrome (AGS)
Assistance Publique - Hôpitaux de Paris
 2015-09-10 PHASE2
NCT01900106 COMPLETED
HIV Infection
University of Modena and Reggio Emilia
 2013-11 PHASE3
NCT02470650 WITHDRAWN
Patient Compliance; Antiretroviral Therapy Intolerance
Juan A. Arnaiz
 2015-06 PHASE4
NCT02596334 TERMINATED
HIV
Centre Hospitalier Régional d'Orléans
 2015-12-23 PHASE3
NCT02605954 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-18 PHASE3
NCT02603107 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-20 PHASE3
NCT02607930 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-13 PHASE3
NCT03316534 COMPLETED
HIV-infected Patients
Azienda Ospedaliera di Perugia
 2017-01-02 PHASE2
NCT02509195 COMPLETED
HIV
St Stephens Aids Trust
 2015-08-04 PHASE4
NCT03178084 COMPLETED
HIV/AIDS
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
 2014-10-15 PHASE3
NCT02893488 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2016-09-01 PHASE1
NCT02159599 COMPLETED
HIV Infection
Fundacion SEIMC-GESIDA
 2014-07 PHASE4
NCT02708342 Completed
HIV
IRCCS San Raffaele|Merck Sharp & Dohme LLC
 2016-04 --
NCT02093585 COMPLETED
HIV
Jan Gerstoft
 2014-01 PHASE4
NCT02246998 COMPLETED
HIV-1 Infection
Gilead Sciences
 2014-12-15 PHASE4
NCT02067767 COMPLETED
HIV-1 Infection
Nantes University Hospital
 2014-02 PHASE2
NCT02539576 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2015-10 PHASE1
NCT01910402 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2013-08-22 PHASE3
NCT02120352 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2014-04-28 PHASE2
NCT01656122 COMPLETED
HIV
The HIV Netherlands Australia Thailand Research Collaboration
 2012-07 PHASE2; PHASE3
NCT02105987 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-04 PHASE3
NCT01146873 COMPLETED
HIV/AIDS; HIV Infections
Columbia University
 2010-07 PHASE3
NCT01352715 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2012-03-13 PHASE3
NCT01389063 UNKNOWN
Endothelial Dysfunction
S.F.L. van Lelyveld
 2012-01 PHASE4
NCT02101216 COMPLETED
Psoriasis
Cellceutix Corporation
 2014-03 PHASE1
NCT01886638 COMPLETED
HIV; Cardiovascular Disease
Bayside Health
 2013-08 PHASE4
NCT01641809 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2012-08-06 PHASE2
NCT00928187 COMPLETED
HIV; HIV Infections
ANRS, Emerging Infectious Diseases
 2009-11 PHASE3
NCT01059422 COMPLETED
HIV Infections; Tuberculosis
Central Institute of Epidemiology, Moscow, Russia
 2010-10 PHASE4
NCT01608269 COMPLETED
HiV1- Positive
Therapeutic Concepts
 2010-11 PHASE4
NCT01499199 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2012-01 PHASE3
NCT00102960 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-07 PHASE3
NCT01052701 COMPLETED
Hepatitis C; HIV
Johns Hopkins University
 2009-12 PHASE1
NCT01622790 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2012-06 PHASE1
NCT00865007 COMPLETED
HIV Infection; Lipodystrophy; HIV Infections
Fundacion SEIMC-GESIDA
 2008-12 PHASE4
NCT01153217 COMPLETED
HIV
Germans Trias i Pujol Hospital
 2010-07 PHASE3
NCT01102972 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2010-04 PHASE4
NCT01263015 COMPLETED
Infection, Human Immunodeficiency Virus I
ViiV Healthcare
 2011-02-01 PHASE3
NCT00544128 COMPLETED
HIV Infections
International Medical Center of Japan
 2007-10 PHASE4
NCT00234091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-04 PHASE3
NCT01231555 TERMINATED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2010-11-18 PHASE2
NCT01366547 COMPLETED
Healthy Subjects; Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-06 PHASE1
NCT00724711 COMPLETED
HIV Infection
Gilead Sciences
 2008-07 PHASE4
NCT00335322 COMPLETED
Human Immunodeficiency Virus (HIV)
Kirby Institute
 2007-02 PHASE4
NCT01220232 COMPLETED
Healthy Volunteers
Pfizer
 2010-11 PHASE1
NCT00958100 COMPLETED
HIV/AIDS; Antiretroviral Therapy; HIV Infections
Catholic University of the Sacred Heart
 2009-08 PHASE2
NCT00915655 COMPLETED
HIV-1 Infection
Tibotec Pharmaceuticals, Ireland
 2009-07 PHASE2
NCT00647244 COMPLETED
HIV Infections
Aarhus University Hospital
 2008-06 PHASE4
NCT00440947 COMPLETED
Infection, Human Immunodeficiency Virus I; HIV Infection
ViiV Healthcare
 2007-03 PHASE3
NCT00951015 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2009-07-30 PHASE2
NCT00549198 COMPLETED
Infection, Human Immunodeficiency Virus I; HIV Infection
GlaxoSmithKline
 2007-06 PHASE4
NCT00118898 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2005-09 PHASE3
NCT00615810 COMPLETED
HIV Infections
Gilead Sciences
 2008-03 PHASE4
NCT00772902 COMPLETED
HIV-1
Gilead Sciences
 2008-10 PHASE4
NCT00405925 COMPLETED
HIV Infections
Rijnstate Hospital
 2003-03 PHASE3
NCT00740064 UNKNOWN
HIV Infections
Denver Infectious Disease Consultants, PLLC
 2008-05 PHASE4
NCT00834457 COMPLETED
AIDS-related Kaposi's Sarcoma
Parirenyatwa Hospital
 2007-06 PHASE2; PHASE3
NCT00427297 TERMINATED
HIV Infections
University of Washington
 2007-09 PHASE3
NCT00270296 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-06 PHASE2
NCT00765271 COMPLETED
HIV
St Stephens Aids Trust
 2008-05 PHASE1
NCT00450580 COMPLETED
Infection, Human Immunodeficiency Virus I; HIV-1 Infection
ViiV Healthcare
 2007-03 PHASE3
NCT00192634 COMPLETED
HIV Infections
Kirby Institute
 2005-12 PHASE4
NCT00214890 COMPLETED
HIV Infections
University of California, San Diego
 2004-12-07 PHASE2
NCT01973439 COMPLETED
HIV Infection
PENTA Foundation
 2006-07 PHASE1
NCT00244712 COMPLETED
HIV Infection
GlaxoSmithKline
 2005-07 PHASE4
NCT00084149 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-02 PHASE2
NCT00335270 COMPLETED
HIV
Duke University
 2006-03 PHASE4
NCT00851630 COMPLETED
HIV; Tuberculosis
Duke University
 2004-06 PHASE4
NCT00006617 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00356616 TERMINATED
HIV Infections
Germans Trias i Pujol Hospital
 2005-09 PHASE4
NCT00318123 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2004-04 PHASE3
NCT00314626 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2004-11 PHASE3
NCT00338390 COMPLETED
HIV Infections
Hospital de Granollers
 2005-04 PHASE3
NCT00192660 COMPLETED
HIV-Associated Lipodystrophy Syndrome; Cardiovascular Disease
Kirby Institute
 2003-02 PHASE4
NCT00143702 COMPLETED
Acidosis, Lactic
University of British Columbia
 2001-08 PHASE2; PHASE3
NCT00082394 COMPLETED
Infection, Human Immunodeficiency Virus I; HIV Infection
GlaxoSmithKline
 2004-04-26 PHASE4
NCT00094367 COMPLETED
HIV Infection
GlaxoSmithKline
 2004-07 PHASE3
NCT00335192 COMPLETED
HIV
Germans Trias i Pujol Hospital
 2005-01 PHASE4
NCT00053638 COMPLETED
HIV Infection
GlaxoSmithKline
 2003-02 PHASE3
NCT00647946 COMPLETED
Lipodystrophy
Gilead Sciences
 2003-02 PHASE2
NCT00038506 COMPLETED
HIV Infection
ViiV Healthcare
 2002-03 PHASE4
NCT00001119 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 1999-10
NCT00044577 COMPLETED
Infection, Human Immunodeficiency Virus I; HIV Infection
ViiV Healthcare
 2002-07-16 PHASE3
NCT00046176 COMPLETED
Infection, Human Immunodeficiency Virus I; HIV Infection
ViiV Healthcare
 2002-08-26 PHASE3
NCT01982396 COMPLETED
HIV Infection
PENTA Foundation
 2003-01 PHASE1
NCT00000922 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00021463 COMPLETED
HIV Infections; Lipodystrophy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT02182765 TERMINATED
HIV Infections
Boehringer Ingelheim
 1999-04 PHASE1
NCT00002388 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE1
NCT00028314 COMPLETED
HIV Infections; Lipodystrophy; Wasting Disease
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-03
NCT00000864 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00051090 WITHDRAWN
HIV Infections; Hepatitis B
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00078247 COMPLETED
HIV Infections; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-10 PHASE3
NCT00004585 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-10 PHASE4
NCT00000912 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002197 COMPLETED
HIV Infections
Glaxo Wellcome
NCT00002199 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE3
NCT00000919 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002364 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00004981 UNKNOWN
HIV Infections
Glaxo Wellcome
 PHASE3
NCT00000865 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002409 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE3
NCT00002141 COMPLETED
HIV Infections
Burroughs Wellcome
 1994-07 PHASE1
NCT00001086 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002183 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE1
NCT00011895 UNKNOWN
HIV Infections
GlaxoSmithKline
 2001-02 PHASE4
NCT00013520 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00002390 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00270556 COMPLETED
HIV
Gilead Sciences
 2003-01 PHASE2
NCT00011479 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002245 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-04 PHASE3
NCT00000885 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00102206 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002200 COMPLETED
HIV Infections
Glaxo Wellcome
NCT00002198 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE1
NCT00008554 UNKNOWN
HIV Infections
Glaxo Wellcome
 2000-11 PHASE3
NCT00006154 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00002423 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-03 PHASE2
NCT00006152 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00337922 COMPLETED
HIV Infection
GlaxoSmithKline
 2006-07 PHASE4
NCT00005673 COMPLETED
Healthy; HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2000-05 PHASE1
NCT00004855 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000872 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00005017 UNKNOWN
HIV Infections
Glaxo Wellcome
 PHASE4
NCT00009061 UNKNOWN
HIV Infections
Glaxo Wellcome
 2000-11 PHASE3
NCT00002217 COMPLETED
HIV Infections
Glaxo Wellcome
NCT00002362 SUSPENDED
HIV Infections
Triangle Pharmaceuticals
 1999-08 PHASE3
NCT00001758 COMPLETED
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 1997-11 PHASE2
NCT00320307 COMPLETED
HIV Infection
GlaxoSmithKline
 2005-09 PHASE1
NCT00086359 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-07 PHASE3
NCT00002239 COMPLETED
HIV Infections
Hoffmann-La Roche
 1999-05 PHASE2
NCT00001968 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2000-01 PHASE1
NCT00386659 TERMINATED
HIV Infection
Hospital Clinic of Barcelona
 PHASE4
NCT00002391 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE3
NCT00005018 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-07 PHASE4
NCT00340080 COMPLETED
HIV Infection
GlaxoSmithKline
 2006-04 PHASE4
NCT00002440 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00426296 UNKNOWN
HIV Infections; Lipodystrophy
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
 2006-08 PHASE4
NCT00139178 COMPLETED
HIV Associated Lipodystrophy Syndrome.; HIV; Hypercholesterolemia; Lipoatrophy
Danish HIV Research Group
 2004-03 PHASE4
NCT00002216 COMPLETED
HIV Infections
Glaxo Wellcome
NCT00087945 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-07
NCT00002419 COMPLETED
HIV Infections
Gilead Sciences
 PHASE2
NCT00002213 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00005106 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-09 PHASE4
NCT00006578 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002233 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00002205 COMPLETED
HIV Infections
Glaxo Wellcome
NCT00085943 COMPLETED
HIV Infection; Infection, Human Immunodeficiency Virus
GlaxoSmithKline
 2004-05 PHASE3
NCT00001132 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 1999-11 PHASE2
NCT00005764 COMPLETED
HIV Infections; Lipodystrophy
Glaxo Wellcome
 2000-05 PHASE4
NCT00021489 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002389 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE3
NCT00000940 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 1999-05 PHASE2
NCT00002163 COMPLETED
AIDS Dementia Complex; HIV Infections
Glaxo Wellcome
 PHASE3
NCT00031070 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00001766 COMPLETED
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 1998-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the Abacavir sulfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Abacavir sulfate is a nucleoside reverse transcriptase inhibitor that undergoes intracellular conversion to its active metabolite, carbovir 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase and incorporates into viral DNA to cause strand termination. By halting viral DNA synthesis and preventing viral replication, this target inhibition effectively lowers viral load in patients with HIV-1 infection.

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.