Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002179
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multiclinic Open Study to Evaluate the Ability of the Combination of Indinavir Zidovudine and Lamivudine to Result in Sustained Suppression of HIV-1 in Asymptomatic HIV-1 Seropositive Patients
Status:
COMPLETED
Status Verified Date:
1999-06
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 evaluate the ability of the combination of indinavir zidovudine and lamivudine to suppress HIV-1 infection as measured by 1 the maintenance of HIV-1 serum viral RNA below the limit of detection of the most sensitive validated assay ultradirect assay and 2 absence of evidence of infectious virus in lymph node cerebrospinal fluid CSF peripheral mononuclear cells PBMCs and semen
It is hypothesized that the administration of indinavir zidovudine and lamivudine will result in
1 No evidence of infectious virus in lymph node tissue CSF PBMCs and semen samples in 50 of patients who have undetectable viral RNA by the most sensitive validated assay available ultradirect assay for at least 48 weeks
2 Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25 of patients
3 Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay ie negative in at least 90 of patients by Week 16
4 Suppression of HIV-1 infection suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir zidovudine and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy
It is hypothesized that the administration of indinavir zidovudine and lamivudine will result in
1 No evidence of infectious virus in lymph node tissue CSF PBMCs and semen samples in 50 of patients who have undetectable viral RNA by the most sensitive validated assay available ultradirect assay for at least 48 weeks
2 Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25 of patients
3 Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay ie negative in at least 90 of patients by Week 16
4 Suppression of HIV-1 infection suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir zidovudine and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy
Detailed Description:
It is hypothesized that the administration of indinavir zidovudine and lamivudine will result in
1 No evidence of infectious virus in lymph node tissue CSF PBMCs and semen samples in 50 of patients who have undetectable viral RNA by the most sensitive validated assay available ultradirect assay for at least 48 weeks
2 Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25 of patients
3 Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay ie negative in at least 90 of patients by Week 16
4 Suppression of HIV-1 infection suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir zidovudine and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy
All patients receive indinavir plus zidovudine plus lamivudine for at least 96 weeks If there is no evidence of infectious virus and patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay for at least 96 weeks therapy is continued for an additional 24 weeks However during this additional 24 weeks of therapy patients may continue to receive this triple combination drug regimen or make changes to this drug regimen treatment by reducing their number of antiretroviral agents After 120 weeks if patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay patients discontinue all antiretroviral therapy However if there is any evidence of infectious virus as outlined above patients do not discontinue therapy Patients who develop detectable serum viral RNA following discontinuation of therapy are given the option to reinitiate therapy with the triple combination of indinavir zidovudine and lamivudine NOTE Patients who develop an intolerance to zidovudine may use stavudine at doses per body weight at the direction of the investigator
1 No evidence of infectious virus in lymph node tissue CSF PBMCs and semen samples in 50 of patients who have undetectable viral RNA by the most sensitive validated assay available ultradirect assay for at least 48 weeks
2 Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25 of patients
3 Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay ie negative in at least 90 of patients by Week 16
4 Suppression of HIV-1 infection suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir zidovudine and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy
All patients receive indinavir plus zidovudine plus lamivudine for at least 96 weeks If there is no evidence of infectious virus and patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay for at least 96 weeks therapy is continued for an additional 24 weeks However during this additional 24 weeks of therapy patients may continue to receive this triple combination drug regimen or make changes to this drug regimen treatment by reducing their number of antiretroviral agents After 120 weeks if patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay patients discontinue all antiretroviral therapy However if there is any evidence of infectious virus as outlined above patients do not discontinue therapy Patients who develop detectable serum viral RNA following discontinuation of therapy are given the option to reinitiate therapy with the triple combination of indinavir zidovudine and lamivudine NOTE Patients who develop an intolerance to zidovudine may use stavudine at doses per body weight at the direction of the investigator
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 |
|---|---|---|---|
| MK-0639 | None | None | None |