Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000919
Status:
COMPLETED
Last Update Posted:
2012-06-07
First Post:
1999-11-02
Brief Title:
A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Study of Protease Inhibitor andor Non-Nucleoside Reverse Transcriptase Inhibitor With Dual Nucleosides in Initial Therapy of HIV Infection
Status:
COMPLETED
Status Verified Date:
2012-06
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:
The purpose of this study is to compare the effectiveness of various combinations of anti-HIV drugs in HIV-positive men and women Patients receive specific combinations of 3 or 4 of the following 6 drugs didanosine ddI stavudine d4T efavirenz EFV nelfinavir NFV lamivudine 3TC or zidovudine ZDV
Anti-HIV therapy is effective in preventing the spread of HIV in the body However patients often experience unpleasant side effects and have difficulties following the dosing schedule This study looks for combinations of anti-HIV drugs cocktails which will be the most effective with the fewest problems
Anti-HIV therapy is effective in preventing the spread of HIV in the body However patients often experience unpleasant side effects and have difficulties following the dosing schedule This study looks for combinations of anti-HIV drugs cocktails which will be the most effective with the fewest problems
Detailed Description:
Highly active antiretroviral therapy though effective in the suppression of HIV proliferation is often complicated by difficulties with adherence and drug toxicity Various combinations of highly active antiretroviral therapy exist all have proved efficacious in related trials The question addressed in this trial is which combination of antiretroviral cocktails provides the single greatest advantage in preventing the spread of HIV in the body In effect which therapy provides the greatest benefit with the fewest complications
Step 1 Patients are randomized to 1 of 6 arms
Arm A didanosine ddI stavudine d4T efavirenz EFV and nelfinavir NFV placebo
Arm B ddI d4T EFV placebo and NFV Arm C lamivudine 3TCzidovudine ZDV EFV and NFV placebo Arm D 3TCZDV EFV placebo and NFV Arm E ddI d4T EFV and NFV Arm F 3TCZDV EFV and NFV Patients with virologic failure on 2 successive measurements or study-drug intolerance discontinue their randomized study therapy and proceed to Step 2 AS PER AMENDMENT 7500 Patients must switch regimens as soon as possible after confirmation of virologic failure to prevent development of drug resistance
Step 2
Arm A Patients receive treatment as in Arm D of Step 1 Arm B Patients receive treatment as in Arm C of Step 1 Arm C Patients receive treatment as in Arm B of Step 1 Arm D Patients receive treatment as in Arm A of Step 1 Arms A B C and D Patients who fail Step 2 treatment proceed to Step 3 Arms E and F Patients with virologic failure on Step 1 proceed immediately to Step 3
Step 3 salvage therapy
Arm A B C and D Patients receive indinavir IDV amprenavir APV ddI and hydroxyurea HU
AS PER AMENDMENT 7500 Patients now receive treatment on Regimen 1 2 3 4 5 or 6 Regimen 1 consists of IDV ritonavir RTV ddI and HU Regimen 2 consists of APV RTV ddI and HU Regimen 3 consists of IDV RTV abacavir ABC and 3TCZDV Regimen 4 consists of APV RTV ABC and 3TCZDV Regimen 5 consists of IDV RTV ABC d4T and 3TC Regimen 6 consists of APV RTV ABC d4T and 3TC Arm E Patients receive IDV APV and 3TCZDV AS PER AMENDMENT 7500 Patients now receive treatment on Regimen 7 or 8 Regimen 7 consists of IDV RTV and 3TCZDV Regimen 8 consists of APV RTV and 3TCZDV Arm F Patients receive IDV APV ddI and d4T AS PER AMENDMENT 7500 Patients now receive treatment on Regimen 9 or 10 Regimen 9 consists of IDV RTV ddI and d4T Regimen 10 consists of APV RTV ddI and d4T AS PER AMENDMENT 7500 Patients already enrolled in Step 3 before site registration to Version 40 of this protocol have the option of receiving 1 of the appropriate new Step 3 regimens as outlined above or staying on their originally assigned Step 3 therapy AS PER AMENDMENT 32101 If virologic failure on Step 1 or 2 is confirmed then HIV-1 RNA genotype resistance testing in real-time if possible is performed Patients receive 1 of the Step 3 drug regimens based on the results of the resistance testing Patients may co-enroll in metabolic pharmacologic immunologic or adherence substudies
Step 1 Patients are randomized to 1 of 6 arms
Arm A didanosine ddI stavudine d4T efavirenz EFV and nelfinavir NFV placebo
Arm B ddI d4T EFV placebo and NFV Arm C lamivudine 3TCzidovudine ZDV EFV and NFV placebo Arm D 3TCZDV EFV placebo and NFV Arm E ddI d4T EFV and NFV Arm F 3TCZDV EFV and NFV Patients with virologic failure on 2 successive measurements or study-drug intolerance discontinue their randomized study therapy and proceed to Step 2 AS PER AMENDMENT 7500 Patients must switch regimens as soon as possible after confirmation of virologic failure to prevent development of drug resistance
Step 2
Arm A Patients receive treatment as in Arm D of Step 1 Arm B Patients receive treatment as in Arm C of Step 1 Arm C Patients receive treatment as in Arm B of Step 1 Arm D Patients receive treatment as in Arm A of Step 1 Arms A B C and D Patients who fail Step 2 treatment proceed to Step 3 Arms E and F Patients with virologic failure on Step 1 proceed immediately to Step 3
Step 3 salvage therapy
Arm A B C and D Patients receive indinavir IDV amprenavir APV ddI and hydroxyurea HU
AS PER AMENDMENT 7500 Patients now receive treatment on Regimen 1 2 3 4 5 or 6 Regimen 1 consists of IDV ritonavir RTV ddI and HU Regimen 2 consists of APV RTV ddI and HU Regimen 3 consists of IDV RTV abacavir ABC and 3TCZDV Regimen 4 consists of APV RTV ABC and 3TCZDV Regimen 5 consists of IDV RTV ABC d4T and 3TC Regimen 6 consists of APV RTV ABC d4T and 3TC Arm E Patients receive IDV APV and 3TCZDV AS PER AMENDMENT 7500 Patients now receive treatment on Regimen 7 or 8 Regimen 7 consists of IDV RTV and 3TCZDV Regimen 8 consists of APV RTV and 3TCZDV Arm F Patients receive IDV APV ddI and d4T AS PER AMENDMENT 7500 Patients now receive treatment on Regimen 9 or 10 Regimen 9 consists of IDV RTV ddI and d4T Regimen 10 consists of APV RTV ddI and d4T AS PER AMENDMENT 7500 Patients already enrolled in Step 3 before site registration to Version 40 of this protocol have the option of receiving 1 of the appropriate new Step 3 regimens as outlined above or staying on their originally assigned Step 3 therapy AS PER AMENDMENT 32101 If virologic failure on Step 1 or 2 is confirmed then HIV-1 RNA genotype resistance testing in real-time if possible is performed Patients receive 1 of the Step 3 drug regimens based on the results of the resistance testing Patients may co-enroll in metabolic pharmacologic immunologic or adherence substudies
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 |
|---|---|---|---|
| AACTG 731 | Registry Identifier | DAIDS ES | None |
| 11343 | REGISTRY | None | None |
| AACTG A5005s | None | None | None |
| AACTG A5006s | None | None | None |
| AACTG A5007s | None | None | None |
| AACTG A5031s | None | None | None |