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Levocarnitine

Phase 3

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Trials Updated: Jun 24, 2005

Levocarnitine development status

Highest phase Phase 3 run by National Institute of Allergy and Infectious Diseases (NIAID) (NCT00001082)
Phase scored for GILDPhase 2
Registered trials 10 across 3 sponsors since Aug 2001

Success Probability

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLED
Total Trials2
Total Enrollment220

FDA Designations

No designations recorded

Levocarnitine clinical trials

Levocarnitine · 2 trials · 1 indication

Phase 2 2
NCT00002184A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected PatientHIV Infections
COMPLETED120 Analytics
NCT00002379The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV DrugsHIV Infections
COMPLETED100 Analytics
PHASE2COMPLETED
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
HIV InfectionsUnlock trial analytics
PHASE2COMPLETED
The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
HIV InfectionsUnlock trial analytics

Study Design & Arms

MaskingDOUBLE
PurposeTREATMENT

Interventions

NameTypeDescription
Nelfinavir mesylateDRUG -
LevocarnitineDRUG -
Adefovir dipivoxilDRUG -
SaquinavirDRUG -
LamivudineDRUG -
StavudineDRUG -
ZidovudineDRUG -
Indinavir sulfateDRUG -
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria Patients must have: * Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture). * An HIV-1 RNA plasma titer \>= 5000 copies/ml within 14-21 days prior to the baseline visit. * CD4 cell count \>= ...

Countries:United StatesPuerto Rico
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Frequently asked questions about Levocarnitine

What is levocarnitine?

Levocarnitine is a small molecule drug that Gilead Sciences, Inc. is developing for HIV Infections. It has been studied in Phase 2 clinical trials as part of combination anti-HIV treatment regimens. It is an investigational agent in this program rather than an approved therapy for HIV.

Who makes levocarnitine?

Levocarnitine is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. The company sponsored the Phase 2 HIV studies of the drug. Gilead is the developer associated with this asset in the HIV Infections program.

What phase is levocarnitine in?

Levocarnitine is in Phase 2 development for HIV Infections. Two Phase 2 trials have been conducted, and both are now completed, with no active trials currently listed. The program enrolled a total of 220 patients across those studies.

What clinical trials is levocarnitine in?

Levocarnitine has been studied in two completed Phase 2 trials: NCT00002379, which enrolled 100 patients, and NCT00002184, which enrolled 120 patients. Both trials were conducted in the United States and Puerto Rico in HIV-infected patients aged 16 years and older.

What was studied in the levocarnitine HIV trials?

The two Phase 2 trials evaluated levocarnitine-containing combination therapy in HIV-infected patients. NCT00002379 examined a regimen including adefovir dipivoxil plus indinavir combined with zidovudine, lamivudine, or stavudine in patients who had not previously taken anti-HIV drugs. NCT00002184 was a stratified, randomized, double-blind study of two dose levels in triple combination therapy.

How many patients were enrolled in levocarnitine trials?

A total of 220 patients were enrolled across the two completed Phase 2 trials of levocarnitine. NCT00002379 enrolled 100 patients and NCT00002184 enrolled 120 patients. Both studies were conducted in HIV-infected patients aged 16 years and older in the United States and Puerto Rico.