Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000892
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Activity of the Soft Gelatin Capsule of Saquinavir SQVsgc in Combination With Ritonavir or Nelfinavir and Combinations of Delavirdine andor Adefovir Dipivoxil in HIV-Infected Subjects With Prior Indinavir Use and Viral Loads From 2000 to 200000 Copies HIV RNAml
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copiesml after 16 weeks of treatment To assess the safety toxicity and tolerance of each treatment arm
While indinavir is currently the most commonly prescribed protease inhibitor the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors saquinavirnelfinavir or saquinavirritonavir and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure This may involve the use of 1 or more reverse transcriptase inhibitors RTIs or nonnucleoside reverse transcriptase inhibitors NNRTIs This study attempts to formally evaluate some of these options in indinavir-experienced patients
While indinavir is currently the most commonly prescribed protease inhibitor the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors saquinavirnelfinavir or saquinavirritonavir and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure This may involve the use of 1 or more reverse transcriptase inhibitors RTIs or nonnucleoside reverse transcriptase inhibitors NNRTIs This study attempts to formally evaluate some of these options in indinavir-experienced patients
Detailed Description:
While indinavir is currently the most commonly prescribed protease inhibitor the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors saquinavirnelfinavir or saquinavirritonavir and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure This may involve the use of 1 or more reverse transcriptase inhibitors RTIs or nonnucleoside reverse transcriptase inhibitors NNRTIs This study attempts to formally evaluate some of these options in indinavir-experienced patients
Patients are stratified by HIV RNA 2000 - 20000 copiesml versus 20000 - 200000 copiesml and randomized to 1 of 6 treatment arms as follows
Arm A Saquinavir SQV plus ritonavir RTV plus delavirdine DLV plus adefovir dipivoxil placebo
Arm B SQV plus RTV plus DLV placebo plus adefovir dipivoxil Arm C SQV plus RTV plus DLV plus adefovir dipivoxil Arm D SQV plus nelfinavir NFV plus DLV plus adefovir dipivoxil placebo Arm E SQV plus NFV plus DLV placebo plus adefovir dipivoxil Arm F SQV plus NFV plus DLV plus adefovir dipivoxil In addition to assigned study treatment patients receive an L-carnitine supplement
Therapy is administered for 24 weeks Patients who have an average HIV RNA value for Weeks 12 and 16 that is less than 5000 copies or a least 1 log below their baseline value may continue their assigned study treatment for an additional 24 weeks AS PER AMENDMENT 33098 Subjects with plasma HIV RNA greater than 5000 copiesml may elect to continue or discontinue study medications in the treatment extension and seek the best available treatment AS PER AMENDMENT 061198 The dose of adefovir dipivoxil is reduced at or after Week 16 Alternatively patients may discontinue adefovir dipivoxilplacebo and substitute appropriate antiretroviral agents or add appropriate antiretroviral agents to their reduced-dose regimen Also at the discretion of the protocol chairperson patients who have been on study for more than 16 weeks may substitute appropriate FDA-approved antiretroviral agents for any study medication that must be discontinued because of toxicity Addition of nonnucleoside reverse transcriptase inhibitors protease inhibitors or investigational agents is specifically excluded
Patients are stratified by HIV RNA 2000 - 20000 copiesml versus 20000 - 200000 copiesml and randomized to 1 of 6 treatment arms as follows
Arm A Saquinavir SQV plus ritonavir RTV plus delavirdine DLV plus adefovir dipivoxil placebo
Arm B SQV plus RTV plus DLV placebo plus adefovir dipivoxil Arm C SQV plus RTV plus DLV plus adefovir dipivoxil Arm D SQV plus nelfinavir NFV plus DLV plus adefovir dipivoxil placebo Arm E SQV plus NFV plus DLV placebo plus adefovir dipivoxil Arm F SQV plus NFV plus DLV plus adefovir dipivoxil In addition to assigned study treatment patients receive an L-carnitine supplement
Therapy is administered for 24 weeks Patients who have an average HIV RNA value for Weeks 12 and 16 that is less than 5000 copies or a least 1 log below their baseline value may continue their assigned study treatment for an additional 24 weeks AS PER AMENDMENT 33098 Subjects with plasma HIV RNA greater than 5000 copiesml may elect to continue or discontinue study medications in the treatment extension and seek the best available treatment AS PER AMENDMENT 061198 The dose of adefovir dipivoxil is reduced at or after Week 16 Alternatively patients may discontinue adefovir dipivoxilplacebo and substitute appropriate antiretroviral agents or add appropriate antiretroviral agents to their reduced-dose regimen Also at the discretion of the protocol chairperson patients who have been on study for more than 16 weeks may substitute appropriate FDA-approved antiretroviral agents for any study medication that must be discontinued because of toxicity Addition of nonnucleoside reverse transcriptase inhibitors protease inhibitors or investigational agents is specifically excluded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11324 | REGISTRY | DAIDS ES | None |