Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084136
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2004-06-07
Brief Title:
Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive HIV Infected Persons in Resource-limited Settings
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
Randomized Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings PEARLS Trial
Status:
COMPLETED
Status Verified Date:
2018-09
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:
PEARLS
Brief Summary:
This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens Participants were recruited from resource-limited areas in Africa Asia South America Haiti and also from the United States The study hypothesis was each of the once daily combinations PI based or NNRTI based would not have inferior efficacy compared to the twice daily NNRTI based combination
Detailed Description:
In developed countries standard effective antiretroviral ARV therapy for treatment-naive HIV infected people includes three-drug combinations of two nucleoside reverse transcriptase inhibitors NRTIs with either a protease inhibitor PI or a non-nucleoside reverse transcriptase inhibitor NNRTI However direct comparisons of ARV efficacy in persons that more closely reflect the worldwide demographics of HIV-1 infection are needed Trial participants were recruited in Africa Malawi South Africa Zimbabwe Asia India Thailand South America Brazil Peru Haiti and the United States
All participants were randomly assigned to one of three arms and random allocation was stratified by 2 factors country and screening plasma HIV-1 RNA level 100000 copiesmL versus 100000 copiesmL Participants assigned to the ZDV3TCEFV arm received lamivudinezidovudine twice daily and efavirenz once daily Participants assigned to the ddIFTCATV arm received emtricitabine atazanavir and enteric-coated didanosine once daily Participants assigned to the TDFFTCEFV arm received emtricitabine tenofovir disoproxil fumarate and efavirenz once daily
Physical exam and blood collection occurred at entry and at most study visits Participants experiencing virologic failure were offered a switch to another regimen
On May 23 2008 the ddIFTCATV was closed following a planned interim review by the studys independent Data and Safety Monitoring Board DSMB The DSMB recommendation was based upon compelling evidence that this arm had significantly more virologic failure and therefore was inferior when compared to the ZDV3TCEFV arm Participants still receiving ddIFTCATV were offered alternative medications and all participants continued to be followed
On November 3 2009 the DSMB recommended that the study close to all follow-up on May 31 2010 before the designed termination based on 30 of participants meeting the primary outcome was met The board observed that the recent accumulation of primary efficacy events ie regimen failures was very slow Therefore if the study were to continue another 1-2 years the precision gained for treatment comparisons would likely be small
All participants were randomly assigned to one of three arms and random allocation was stratified by 2 factors country and screening plasma HIV-1 RNA level 100000 copiesmL versus 100000 copiesmL Participants assigned to the ZDV3TCEFV arm received lamivudinezidovudine twice daily and efavirenz once daily Participants assigned to the ddIFTCATV arm received emtricitabine atazanavir and enteric-coated didanosine once daily Participants assigned to the TDFFTCEFV arm received emtricitabine tenofovir disoproxil fumarate and efavirenz once daily
Physical exam and blood collection occurred at entry and at most study visits Participants experiencing virologic failure were offered a switch to another regimen
On May 23 2008 the ddIFTCATV was closed following a planned interim review by the studys independent Data and Safety Monitoring Board DSMB The DSMB recommendation was based upon compelling evidence that this arm had significantly more virologic failure and therefore was inferior when compared to the ZDV3TCEFV arm Participants still receiving ddIFTCATV were offered alternative medications and all participants continued to be followed
On November 3 2009 the DSMB recommended that the study close to all follow-up on May 31 2010 before the designed termination based on 30 of participants meeting the primary outcome was met The board observed that the recent accumulation of primary efficacy events ie regimen failures was very slow Therefore if the study were to continue another 1-2 years the precision gained for treatment comparisons would likely be small
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 |
|---|---|---|---|
| 1U01AI068636 | NIH | None | None |
| PEARLS | None | None | None |
| A5185s | None | None | None |
| 5K24AI051966-03 | NIH | None | httpsreporternihgovquickSearch5K24AI051966-03 |