Viewing Study NCT00013520



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Study NCT ID: NCT00013520
Status: COMPLETED
Last Update Posted: 2012-05-21
First Post: 2001-03-16

Brief Title: Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: Phase III Randomized Double-Blind Comparison of Three Protease Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection
Status: COMPLETED
Status Verified Date: 2012-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
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 safety and tolerability of 3 anti-HIV combination treatments that do not use protease inhibitors PIs

The current rule for starting treatment of HIV infection is to combine members from different classes of anti-HIV drugs such as 2 nucleoside reverse transcriptase inhibitors NRTIs and either a PI or a nonnucleoside reverse transcriptase inhibitor NNRTI However these combinations can be complicated and difficult to take can cause a number of side effects and may become ineffective Combinations that are simpler better tolerated and more effective are needed Because PIs can cause long-term side effects and because HIV can become resistant to many of them at the same time anti-HIV combination treatments that do not use PIs are being tested
Detailed Description: Current treatment guidelines recommend combination regimens of 2 nucleoside analogues with either a PI or an NNRTI for the initial treatment of HIV infection However the efficacy of current regimens is limited by their complexity pharmacokinetic characteristics short- and long-term side effects and drug-resistance profiles at the time of virologic failure Consequently the identification of new initial regimens that are simpler better tolerated preserve treatment options in the event of failure and improve antiretroviral potency is needed In addition recent concern over the long-term toxicities of PIs and the extensive cross-resistance among the available PIs have led to the testing of PI-sparing regimens

Participants will be in this study for a minimum of 120 weeks and a maximum of approximately 4 years In Step 1 patients are randomly selected to receive 1 of 3 blinded treatment regimens abacavir ABClamivudine 3TCzidovudine ZDVefavirenz EFV ABC3TCZDV or 3TCZDVEFV Patients with confirmed virologic failure on Step 1 and two successive plasma HIV RNA levels of 10000 copiesml or greater must register to Step 2 Patients with confirmed virologic failure on Step 1 and whose plasma HIV RNA is under 10000 copiesml may remain on Step 1 or register to Step 2 AS PER AMENDMENT 041103 Discontinuation of Arm B was recommended Consequently Arms A and C were unblinded to EFV but not to ABC A number of options are available for patients originally randomized to Arm B

Step 2 is open label Regimens include 2 or 3 nucleoside reverse transcriptase inhibitors NRTIs in combination with EFV atazanavir ATZ ritonavir-boosted ATZ or tenofovir disoproxil fumarate TDF Patients on Arm B treatment who have an HIV RNA level less than 200 copiesml within the past 8 weeks are eligible for randomization to open-label intensification of Arm B on Step 3

Step 3 regimens include ABC3TCZDV plus either EFV or TDF Patients with evidence of treatment-limiting toxicity to Step 3 study drugs have the option of substituting d4T for ZDV ddI for ABC or TDF andor NVP for EFV Patients with confirmed virologic failure on Step 3 and whose plasma HIV RNA is less than 10000 copiesml may either remain on Step 3 or register to Step 4 Patients with two successive plasma HIV RNA levels of 10000 copiesml or greater on Step 3 must register to Step 4

Step 4 is open label Regimens include two or three NRTIs plus EFV ATV ritonavir-boosted ATV or TDF Clinical assessments and laboratory evaluations are done at entry at Weeks 2 4 6 8 12 16 20 24 and then every 8 weeks thereafter for the duration of the study Evaluations are also required when a protocol-allowed drug substitution is made

In addition 3 substudies are being conducted a neurology substudy for efavirenz a pharmacology substudy for atazanavir and a viral dynamics substudy

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
10212 REGISTRY None None
ACTG A5095 None None None
AACTG A5095 None None None
Substudy ACTG A5097s None None None
Substudy AACTG 5107s None None None
Substudy AACTG 5166s None None None
Substudy ACTG A5166s None None None
Substudy AACTG 5097s None None None
Substudy ACTG A5107s None None None
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