Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002398
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Giving Adefovir Preveon Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Open-Label Expanded Access Program to Evaluate the Safety of Preveon Adefovir Dipivoxil at Two Dose Levels When Used in Combination With Other Antiretroviral Agents for the Treatment of Patients With HIV Infection Who Have Failed Other Antiretroviral Therapy and Have Limited Treatment Options
Status:
COMPLETED
Status Verified Date:
1999-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if it is safe and effective to give adefovir plus other anti-HIV drugs to HIV-infected patients who have failed other anti-HIV drug combinations This study will try to make adefovir available to all AIDS patients who need it
Some patients do not respond to anti-HIV drug combinations even when different combinations are tried Adefovir may be able to help these patients fight HIV
Some patients do not respond to anti-HIV drug combinations even when different combinations are tried Adefovir may be able to help these patients fight HIV
Detailed Description:
Recent studies indicate that the use of triple-combination therapy in particular the combinations of reverse transcriptase inhibitors and a protease inhibitor can result in a significant decrease in plasma HIV-1 RNA levels and an increase in CD4 cell count Continued follow-up of patients taking triple-combination drug regimens has in some cases demonstrated sustained suppression of plasma HIV-1 RNA levels for up to 18 months Furthermore despite the potent antiviral effect of some triple combinations a percentage of patients continue to have measurable levels more than 500 copiesml of HIV-1 RNA in plasma even when treated with a combination of 2 reverse transcriptase inhibitors and indinavir Over time some patients experience a rebound of plasma HIV-1 RNA for reasons that are not well understood AS PER AMENDMENT 7898 Randomization to 2 dose levels may allow more patients to derive therapeutic benefit from Preveon by minimizing adverse effects
Patients not previously enrolled in clinical trials of Preveon are randomized to 1 of 2 doses of Preveon orally once daily and L-carnitine orally once daily AS PER AMENDMENT 7898 Patients must receive other antiretroviral agents concomitantly with Preveon at least 1 other antiretroviral agent must be added with Preveon that was not previously administered to the patientPatients previously enrolled in Preveon clinical trials who roll in to expanded access and who have received at least 16 weeks of Preveon receive open-label Preveon orally once daily and L-carnitine orally once daily taken with or without food at the same time each day All patients enrolled in expanded access are randomized in a 11 fashion to 1 of 2 doses taken orally once daily Patients initially assigned to the higher dose will have their Preveon dose reduced to the lower dose at Week 16 of treatment Patients initially assigned to the lower dose continue this dose unless dose modification to an even lower dose for toxicity is required AS PER AMENDMENT 7898 Additional informed consent is needed for this reduction due to limited efficacy of the lower dosage in treating HIV infection
Patients not previously enrolled in clinical trials of Preveon are randomized to 1 of 2 doses of Preveon orally once daily and L-carnitine orally once daily AS PER AMENDMENT 7898 Patients must receive other antiretroviral agents concomitantly with Preveon at least 1 other antiretroviral agent must be added with Preveon that was not previously administered to the patientPatients previously enrolled in Preveon clinical trials who roll in to expanded access and who have received at least 16 weeks of Preveon receive open-label Preveon orally once daily and L-carnitine orally once daily taken with or without food at the same time each day All patients enrolled in expanded access are randomized in a 11 fashion to 1 of 2 doses taken orally once daily Patients initially assigned to the higher dose will have their Preveon dose reduced to the lower dose at Week 16 of treatment Patients initially assigned to the lower dose continue this dose unless dose modification to an even lower dose for toxicity is required AS PER AMENDMENT 7898 Additional informed consent is needed for this reduction due to limited efficacy of the lower dosage in treating HIV infection
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GS-97-423 | None | None | None |