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1 Clinical Trial Details (PDF Generation Date :- Sun, 30 Dec :34:16 GMT) CTRI Number CTRI/2009/091/ [Registered on: 27/10/2009] - Last Modified On 11/03/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial Protocol No. ACTG 5175 : Protocol Title:EVALUATION OF THE EFFICACY OF ANTIRETROVIRAL THERAPY FOR INITIAL TREATMENT OF HIV-1 INFECTED INDIVIDUALS :-ONCE-DAILY PROTEASE INHIBITOR- AND ONCE-DAILY NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR-CONTAINING THERAPY COMBINATIONS Protocol No. ACTG 5175 : Protocol Title: A PHASE IV, PROSPECTIVE, RANDOMIZED, OPEN-LABEL EVALUATION OF THE EFFICACY OF ONCE-DAILY PROTEASE INHIBITOR- AND ONCE-DAILY NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR-CONTAINING THERAPY COMBINATIONS FOR INITIAL TREATMENT OF HIV-1 INFECTED INDIVIDUALS FROM RESOURCE-LIMITED SETTINGS (PEARLS) TRIAL Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NCT ClinicalTrials.gov Details of Principal Investigator Scientist F Details Contact Person (Scientific Query) ICMR Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Source of Monetary or Material Support > National Institute of Allergy And Infection Diseases (NIAID),USA Primary Sponsor Details National Institute of Allergy And Infection Diseases NIAIDUSA Department of Health and Human Services National Institutes of Health US Type of Sponsor Government funding agency Adult AIDS Clinical Trial Group Department of Health and Human Services National Institutes of Health US List of Countries Thailand of Principal Investigator stripathynariindiaorg of Site Site Phone/Fax/ National AIDS Research Institute, 73 G Block, MIDC, Bhosari , of Committee Approval Status Date of Approval Is Independent Ethics Committee? 2) NARI Ethics Committtee,pune Status Approved/Obtained Health Type Patients Approved 17/06/2010 No Date No Date Specified Condition HIV Infections Type Details Intervention Drug: Atazanavir,Drug: Didanosine (enteric-coated), Drug: Efavirenz,Drug: Emtricitabine,Drug: Emtricitabine/Tenofovir disoproxil fumarate,drug: Lamivudine/Zidovudine Arm B participants will receive emtricitabine, atazanavir, and enteric-coated didanosine for 48 weeks unless virologic failure due to drug resistance occurs HIV Infections Phase IV Drug: Atazanavir 400 mg taken orally daily Drug: Didanosine (enteric-coated) 400 mg taken orally daily Drug: Efavirenz 600 mg taken orally daily Drug: Emtricitabine 200 mg taken orally daily Arm C participants will receive Drug: Efavirenz 600 mg taken page 2 / 5

3 Inclusion Criteria Age From Age To Gender Details emtricitabine/tenofovir disoproxil fumarate and efavirenz for 48 weeks unless virologic failure due to drug resistance occurs Arm A participants will receive lamivudine/zidovudine and efavirenz for 48 weeks unless virologic failure due to drug resistance occurs Year(s) Year(s) Both Inclusion Criteria orally daily Drug: Emtricitabine 200 mg taken orally daily Drug: Emtricitabine/Tenofovir disoproxil fumarate 200 mg/300 mg taken orally once daily Drug: Efavirenz 600 mg taken orally daily Drug: Lamivudine/Zidovudine 150 mg/300 mg taken orally twice daily HIV-1 infected Prior ARV therapy for 7 days or less at any time prior to study entry CD4 count less than 300 cells/mm3 within 90 days prior to study entry Viral load test within 45 days prior to study entry Plans to stay in the area for the duration of the study Willing to adhere to study follow-up schedule Agrees to use acceptable forms of contraception for the duration of the study Virologic failure, defined as two successive viral load tests of 1000 copies/ml or greater OR either progression to AIDS after at least 12 weeks following study entry OR a decrease in CD4 count to less than 50% of the Step 1 maximum in absence of confirmed virologic failure after at least 12 weeks following study entry. More information on this criterion can be found in the protocol. Received counseling on treatment adherence Willing to switch to a new ARV treatment regimen Site investigator recommends a new ARV regimen for the management of presumed or documented drug resistance Received administrative approval to enter Step 2 Exclusion Criteria Details Exclusion Criteria Acute therapy for serious medical illnesses within 14 days prior to study entry. Patients with serious infection who must continue with chronic maintenance therapy must be clinically stable and have completed at least 14 days of therapy prior to study entry. Certain abnormal laboratory values Radiation therapy or chemotherapy within 45 days prior to study entry. Patients on systemic chemotherapy for treatment of Kaposi's sarcoma within 45 days of study entry are not excluded, provided the chemotherapy is completed prior to study entry. Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. Patients taking tapered courses of corticosteroids for acute therapy for Pneumocystis carinii pneumonia (PCP) are not excluded. Current alcohol or drug abuse that, in the opinion of the site investigator, would interfere with study participation Inflamed pancreas within 3 years prior to study entry Currently enrolled in ACTG A5001 or A5164 Allergy/sensitivity to any of the study drugs or their formulations Heart rate less than 40 beats/min History of untreated, active second- or third-degree heart block Require certain medications Currently detained in jail or for treatment of a psychiatric or physical illness Vomiting or inability to swallow medications Any condition that, in the opinion of the site investigator, would compromise study participation Pregnancy page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label Primary Outcome Outcome Timepoints Time to treatment failure, defined as the time from study entry to the first occurrence of virologic failure, disease progression, or death [ Time Frame: At least 12 weeks following study entry. Virologic failure will be measured at the Week 16 visit or later. ] [ Designated as safety issue: No ] at least 12 weeks following randomization. at the week 16 visit or later. Secondary Outcome Outcome Timepoints 1.Time to discontinuation of intitial antiretroviral therapy 2.Time to immunologic failure Change in CD4 count 3.modification or Grade 3 or 4 toxicity 4.Viral load less than 400 copies/ml Time to loss of virologic response [ Time Frame: Throughout the study ] [ Designated as safety issue: No ] 1. Time Frame: Throughout the study 2.at weeks 24 and 48 3.Throughout the study 4.At Weeks 24 and 48 Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=1574 Sample Size from =120 09/11/ /05/2006 Years=4 Months=0 Days=0 Completed Completed Bartlett JA, Johnson J, Herrera G, Sosa N, Rodriguez A, Liao Q, Griffith S, Irlbeck D, Shaefer MS; for the Clinically Significant Long-term Antiretroviral Sequential Sequencing Study (CLASS) Team. Long-Term Results of Initial Therapy With Abacavir and Lamivudine Combined With Efavirenz, Amprenavir/Ritonavir, or Stavudine. J Acquir Immune Defic Syndr Sep 7; [Epub ahead of print] Saag MS. Initiation of antiretroviral therapy: implications of recent findings. Top HIV Med Jul-Aug;12(3):83-8. Review. Tapper ML, Daar ES, Piliero PJ, Smith K, Steinhart C. Strategies for initiating combination antiretroviral therapy. AIDS Patient Care STDS Apr;19(4): Review. ACTG 5175 is a Phase IV, Prospective, Randomized, Open Label Evaluation of the Efficacy of Once Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Individuals from Resource page 4 / 5

5 Powered by TCPDF ( PDF of Trial Limited Settings (PEARLS) Trial.The primary objective of the study is to demonstrate the non-inferiority of a once-daily PI- and a once-daily NNRTI-containing regimen as compared with standard twice-daily ARV therapy for the initial treatment of individuals infected with HIV-1 from diverse areas of the world.the duration of the full study approximately 4 years. The target sample size for the full study was 120 at NARI Site & YRGCARE Chennai was enrolled 135 participants but 121 for regular follow up. page 5 / 5

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