Stavudine
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ZERIT | — | 1995-12-21 – 2002-03-29 | fda.gov ↗ |
| Approved | EU (EMA) | Zerit | — | 1996-05-08 | europa.eu ↗ |
| Approved | US (FDA) | ZERIT | — | 1994-06-24 | fda.gov ↗ |
Trials 89 · started per year
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2004-07-11 | Gilead Sciences | Results Pivotal Studies of Gilead's Viread and Emtriva Published in Special International Aids Conference Issue of Journal of the American Medical Association gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced the publication of results from two separate studies evaluating the efficacy and safety of Viread(R) (tenofovir disoproxil fumarate) and Emtriva(R) (emtricitabine), respectively, compared with stavudine (d4T), in combination with other antiretroviral agents. |
| 2004-02-04 | Gilead Sciences | Results Gilead Announces Data from Landmark Three-Year Clinical Trial of Viread; 144-Week Data Highlight Viread Efficacy, Safety and Side Effect Profile gilead.com ↗
At 144 weeks, treatment with stavudine was associated with greater elevations in fasting triglyceride and cholesterol levels and a notably higher incidence of investigator-defined lipodystrophy compared to treatment with Viread. |
| 2003-10-28 | Gilead Sciences | Results New Data Highlight Safety and Tolerability Profile of Gilead's Viread for Periods up to Four Years; Data Presented at European AIDS Conference in Warsaw gilead.com ↗
Results suggest that the use of Viread may improve dyslipidemia associated with stavudine-based regimens, while maintaining viral suppression. |
| 2003-07-14 | Gilead Sciences | Results Phase III Trial of Emtriva, New Once-Daily Capsule for HIV, Shows Continued Response Through 60 Weeks gilead.com ↗
This study suggests that over time Emtriva continues to outperform stavudine, a thymidine-analogue NRTI, in terms of both its efficacy and tolerability, |
| 2003-06-13 | Gilead Sciences | Results 96-Week Data from Gilead's Study 903 Show Low Rate of Virologic Failure among Patients Taking Viread gilead.com ↗
From week 48 through week 96, the K65R mutation developed in one additional Viread-treated patient resulting in a total of 2.7 percent of patients through 96 weeks versus 0.7 percent in the d4T arm. |
| 2003-02-11 | Gilead Sciences | Results 96-Week Data From Phase III Study Show Long-Term Efficacy With Reduced Risk of Lipid and Metabolic Changes for Viread Versus Stavudine in Treatment-Naive HIV Patients gilead.com ↗
The 96-week results presented today show that the Viread and stavudine arms reduced HIV RNA to less than 400 copies/mL in 82 and 78 percent of patients respectively, using the most conservative "missing equals failure" analysis. |
| 2002-09-27 | Gilead Sciences | Results Phase III Study of Viread Shows Favorable Lipid and Mitochondrial DNA Profile in Treatment-naive HIV Patients; Data Presented in Late-Breaker Session at 42nd ICAAC gilead.com ↗
In addition, the incidence of nucleoside analogue-associated toxicities, such as peripheral neuropathy and lipodystrophy, was three percent in the Viread-containing arm, compared with 10 percent in the stavudine-containing arm (p less than 0.001) after 48 weeks of treatment. |
| 2002-07-08 | Gilead Sciences | Results 48-Week Data Compare Viread to Stavudine When Used as Part of Patients' First Anti-HIV Regimen; Data Presented at XIV International AIDS Conference in Barcelona gilead.com ↗
Importantly, analyses of measurements of laboratory markers reveal that patients in the stavudine arm of the study experienced significant increases in triglyceride and cholesterol levels compared to those in the Viread arm through 48 weeks. |
| 2002-05-07 | Gilead Sciences | Results Gilead Announces Preliminary 48-Week Study Results Showing Viread Comparable to Stavudine in Treatment-Naive HIV Patients gilead.com ↗
These data demonstrate that as a part of combination therapy for 48 weeks Viread can provide efficacy and safety comparable to stavudine, one of the most commonly prescribed nucleoside reverse transcriptase inhibitors. |
| 2001-06-05 | Gilead Sciences | Results Gilead Sciences Presents Data Characterizing Resistance Profile of Tenofovir DF, Investigational Agent for the Treatment of HIV gilead.com ↗
The results demonstrate that chain-terminator removal occurs more readily with nucleosides than nucleotides and may contribute to the higher-level of resistance associated with nucleosides. |
| 1998-09-23 | Gilead Sciences | Results Gilead Sciences Provides Update on PREVEON® Clinical Program for the Treatment of HIV gilead.com ↗
These data demonstrate that PREVEON has durable anti-HIV activity in treatment-experienced patients, including those infected with strains of HIV resistant to most currently approved therapies. |
All press releases naming this drug 11 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 150 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | stavudine | “It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗143“NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF,...” NCT01252940 ↗ “Triomune is manufactured by a generic drug company and consists of three drugs combined in a single pill given twice daily (stavudine 30mg plus lamivudine 150mg plus nevirapine 200mg).” NCT00617643 ↗ “Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.” NCT02002286 ↗ “Triomune® (Cipla, Mumbai) Stavudine 40mg b.d \> 60 kg , 30mg bd \<60kg Lamivudine 150mg b.d \> 50 kg 2mg/kg \< 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks)” NCT00380770 ↗ “The Fixed Drug Combination (FDC) nevirapine (NVP)-lamivudine-stavudine is the first line ART available for low-income countries.” NCT00495326 ↗ “lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);” NCT00650637 ↗ “Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.” NCT00978068 ↗ “Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.” NCT00006441 ↗ “In women who with moderate to severe anemia, ZDV is substituted with stavudine (d4T).” NCT00753324 ↗ “or stavudine 30 mg BID if hemoglobin is \< 8 g/L) and 1 NNRTI” NCT01192035 ↗ |
| Known as | 2',3'-Didehydro-2',3'-Dideoxythymidine | “A Randomized Blinded Evaluation of Two Doses of Stavudine (2',3'-Didehydro-2',3'-Dideoxythymidine; d4T) to Make Treatment Available to Severely Immunocompromised Patients With...” NCT00002308 ↗ |
| Known as | 2',3'-Didehydro-3'-Deoxythymidine | “A Phase I Safety and Pharmacokinetics Study of BMY-27857 (2',3'-Didehydro-3'-Deoxythymidine) Administered Twice Daily to Patients With AIDS or AIDS Related Complex” NCT00000988 ↗ |
| Known as | 2',3'-Dideoxy-2',3'-Didehydrothymidine | “To evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or...” NCT00000988 ↗1“A Phase I Safety Study of BMY-27857 (2',3'-Dideoxy-2',3'-Didehydrothymidine [d4T]) Administered Four Times Daily to AZT-Intolerant Patients With AIDS or AIDS-Related Complex” NCT00000686 ↗ |
| Known as | BMY-27857 | “A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients With HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between...” NCT00002307 ↗2“A Phase I Safety Study of BMY-27857 (2',3'-Dideoxy-2',3'-Didehydrothymidine [d4T]) Administered Four Times Daily to AZT-Intolerant Patients With AIDS or AIDS-Related Complex” NCT00000686 ↗ “A Phase I Safety and Pharmacokinetics Study of BMY-27857 (2',3'-Didehydro-3'-Deoxythymidine) Administered Twice Daily to Patients With AIDS or AIDS Related Complex” NCT00000988 ↗ |
| Known as | d4T | “The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations,...” NCT00116298 ↗80“In Pediatric AIDS Clinical Trials Group (PACTG) Protocol 377, 181 infants and children were assigned to receive stavudine (d4T) plus nevirapine (NVP) and ritonavir (RTV); d4T...” PMID 11880966 ↗ Feb 2002 “A Randomized Blinded Evaluation of Two Doses of Stavudine (2',3'-Didehydro-2',3'-Dideoxythymidine; d4T) to Make Treatment Available to Severely Immunocompromised Patients With...” NCT00002308 ↗ “The efficacy and tolerance of switching from zidovudine (ZDV) and lamivudine (3TC) in clinically stable HIV-infected children with incomplete viral suppression to stavudine...” PMID 11840078 ↗ Feb 2002 “The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir...” NCT00002397 ↗ “An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (Viramune) and Nelfinavir (Viracept) and the Efficacy of This Combination Therapy in HIV-1...” NCT00002381 ↗ “Arm I options are enteric-coated didanosine (ddI-EC) plus lamivudine (3TC), ddI-EC plus zidovudine (ZDV), ZDV plus 3TC (or Combivir), stavudine (d4T) plus 3TC, or ddI-EC plus...” NCT00014937 ↗ “Double reverse transcriptase inhibitor (RTI) therapy consisting of any two therapy combinations of: didanosine (ddI), lamivudine (3TC), stavudine (d4T) or zidovudine (ZDV),...” NCT00002376 ↗ “The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken...” NCT00005918 ↗ “adding stavudine (d4T) to anti-HIV drug regimens (with or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems involving the brain or spinal...” NCT00002246 ↗ “To evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or...” NCT00000988 ↗ |
| Known as | d4T ER | “Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation.” NCT00005918 ↗ |
| Known as | d4T IR | “Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation.” NCT00005918 ↗ |
| Known as | d4T XR | “Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release...” NCT00116116 ↗2“Arms A, B, and C receive the same daily dosage of lopinavir/ritonavir (LPV/r), emtricitabine (FTC), and stavudine extended release (d4T XR) or tenofovir DF (TDF).” NCT00036452 ↗ “stavudine extended release (d4T XR) once daily” NCT00050895 ↗ |
| Known as | Zerit | “An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (Viramune) and Nelfinavir (Viracept) and the Efficacy of This Combination Therapy in HIV-1...” NCT00002381 ↗3“100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) +...” NCT00002369 ↗ “Zerit (Stavudine)” NCT00002168 ↗ “Zerit (Stavudine)” NCT00002420 ↗ |
| Action | Inhibit | “Test-tube and animal studies of d4T show that the drug can inhibit replication (reproduction) of HIV” NCT00000686 ↗ |
| Modality | Other / unclassified | “HIV nucleoside reverse transcriptase inhibitors (NRTI)” PMID 16103764 ↗ Sep 2005 |
| Route | Oral | “oral dosing” NCT00000686 ↗ |