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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00108862 |
The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB).
Study hypothesis: Immediate antiretroviral therapy (ART), initiated within approximately 2 weeks after initiation of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death in HIV infected participants being treated for TB by at least 40% by Week 48 when compared to deferred ART initiated at least 8 weeks after initiation of TB treatment.
Condition | Intervention |
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HIV Infections Tuberculosis |
Drug: Efavirenz Drug: Emtricitabine Drug: Emtricitabine/Tenofovir disoproxil fumarate Drug: Tenofovir disoproxil fumarate Drug: Rifampin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for HIV Infected Persons Treated for Tuberculosis With CD4 Less Than 200 Cells/mm3 |
Estimated Enrollment: | 800 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1A: Experimental
Participants will initiate ART within 2 weeks after initiating TB treatment. Participants in Arm 1A will not enroll in Arm 2.
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Drug: Efavirenz
600 mg tablet taken orally daily
Drug: Emtricitabine
200 mg tablet taken orally daily
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily
Drug: Tenofovir disoproxil fumarate
300 mg tablet taken orally daily
Drug: Rifampin
Participants should continue receiving regimen that was prescribed prior to study entry
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1B: Experimental
Participants will defer ART until 8 to 12 weeks after initiation of their TB treatment. Participants will enroll in Arm 2 after completing Arm 1B.
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Drug: Rifampin
Participants should continue receiving regimen that was prescribed prior to study entry
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2: Experimental
Arm 1B participants will enroll in Arm 2 and initiate ART
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Drug: Efavirenz
600 mg tablet taken orally daily
Drug: Emtricitabine
200 mg tablet taken orally daily
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily
Drug: Tenofovir disoproxil fumarate
300 mg tablet taken orally daily
Drug: Rifampin
Participants should continue receiving regimen that was prescribed prior to study entry
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TB is the most important coinfection in the HIV epidemic; the bi-directional relationship between the two diseases is well established. HIV increases the risk for TB acquisition, reactivation, and reinfection, and reduces survival compared to patients with TB alone. In individuals with HIV, TB infection results in reduced survival, increased risk for opportunistic infections, and elevations in HIV replication. Improving the outcome of HIV infected individuals who develop TB is of high importance. Initiating ART shortly after initiating TB treatment may improve outcomes in individuals coinfected with HIV and TB. However, data to support this suggestion are limited. This study will determine the most appropriate time to initiate ART in HIV infected individuals who recently initiated treatment for TB.
This study will last 48 weeks and will comprise two steps. At study entry, participants will undergo clinical assessment, drug adherence training, and blood collection. In Step 1, participants will be randomly assigned to one of two arms. Participants in Arm A will initiate ART within 2 weeks after initiating TB treatment. Participants in Arm B will defer ART until 8 to 12 weeks after initiation of their TB treatment. In Step 2, Arm B participants will initiate ART; Arm A participants will not enter Step 2. ART will consist of efavirenz and emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF); FTC and TDF may be given as individual agents. Drug substitutions may be made for participants who cannot tolerate the specified regimen. Blood collection and clinical assessments will occur at Weeks 4, 8, 12, 16, 24, 32, 40, and 48.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Harbor General/UCLA | Recruiting |
Torrance, California, United States, 90502-2052 | |
Contact: Mario Guerrero, MD 310-222-3848 mguerrero@rei.edu | |
San Francisco General Francisco General | Recruiting |
San Francisco, California, United States, 94110 | |
Contact: Michele Downing, RN, BSN 415-514-0550 ext 354 mdowning@php.ucsf.edu | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033-1079 | |
Contact: Luis M Mendez 323-343-8283 lmendez@usc.edu | |
United States, New Jersey | |
New Jersey Medical School Adult Clinical Research Center | Recruiting |
Newark, New Jersey, United States | |
Contact: Nancy Reilly, RN 973-972-1268 reillyna@umdnj.edu | |
United States, New York | |
NYU Med. Ctr., Dept. of Medicine | Recruiting |
New York, New York, United States, 10016 | |
Contact: Maura Laverty, RN 212-263-6565 maura.laverty@med.nyu.edu | |
Principal Investigator: Judith A. Aberg, MD | |
United States, Rhode Island | |
The Miriam Hospital | Active, not recruiting |
Providence, Rhode Island, United States, 02906 | |
United States, Texas | |
Thomas Street Clinic CRS | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Hilda Cuervo 713-500-6751 Hilda.Cuervo@uth.tmc.edu | |
Principal Investigator: Roberto C. Arduino, MD | |
Brazil | |
Instituto de Pesquisa Clinica Evandro Chagas | Recruiting |
Rio de Janeiro, Brazil, 21045 | |
Contact: Sandra W. Cardoso 552-125-644933 sandra.wagner@bol.com.br | |
Principal Investigator: Beatriz Grinsztejn, MD, PhD | |
Brazil, RS | |
Hopsital Nossa Senhora da Conceicao/GHC, Servico de Infectogia | Recruiting |
Porto Alegre, RS, Brazil, 91350 | |
Contact: Rita de Cassia Alves Lira, MD 55 51 3361 2911 lrita@ghc.com.br | |
Principal Investigator: Breno Regal Santos, MD | |
Congo, KwaZulu-Natal | |
Durban Adult HIV CRS | Recruiting |
Durban, KwaZulu-Natal, Congo, 4001 | |
Contact: Nonhlanhla Khubone Khubone@ukzn.ac.za | |
Haiti, Port-au-Prince | |
Les Centres GHESKIO CRS | Recruiting |
Bicentenaire, Port-au-Prince, Haiti, HT-6110 | |
Contact: Patrice Severe, MD 509-2222241 patsevere@gheskio.org | |
Principal Investigator: Jean W Pape, MD | |
India | |
Y.R.G Ctr, for AIDS Research and Education | Recruiting |
Chennai, India | |
Contact: Aylur Kailasom Srikrishnan, MBA 91 442 254 2929 krish@yrgcare.org | |
Principal Investigator: Nagalingeshwaran Kumarasamy, MD, PhD | |
Malawi | |
12001 Kamuzu Central Hosp., Tidziwe Ctr. | Recruiting |
Lilongwe, Malawi | |
Contact: Cecelia Kanyama, MBBS 265-175-5056 zayithway@yahoo.co.uk | |
Principal Investigator: Mina C. Hosseinipour, MD, MPH | |
Peru | |
Investigaciones Medicas en Salud | Recruiting |
Lima, Peru, 18 PE | |
Contact: Juan V. Guanira, MD, MPH 51-124-23072 jguanira@impactaperu.org | |
South Africa | |
Univ. of Witwatersrand, CTU | Recruiting |
Johannesburg, South Africa | |
Contact: Pauline C Vunandlala, BS 27 11 717 2810 idsyndicate@witshealth.co.za | |
Principal Investigator: Ian M Sanne, MD, FCP | |
Univ. of KwaZulu-Natal, Nelson Mandela School of Medicine | Recruiting |
Durban, South Africa, 4013 SF | |
Contact: Fawzia Williamson 27 31 260 4365 amodf1@nu.ac.za | |
Principal Investigator: Umesh Gangaram Lalloo, MD, FRCP | |
Thailand | |
Chiang Mai University | Recruiting |
Chiang Maii, Thailand, 50202 | |
Contact: Daralak Tavornprasit +66-53-22196 daralak@rihes-cmu.org |
Study Chair: | Diane Havlir, MD | San Francisco General Hospital and University of California, San Francisco |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5221, AACTG A5221 |
Study First Received: | April 19, 2005 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00108862 |
Health Authority: | United States: Federal Government |
Treatment Naive TB HIV Antiretroviral Agents |
Bacterial Infections Efavirenz Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Rifampin Gram-Positive Bacterial Infections |
Emtricitabine HIV Infections Sexually Transmitted Diseases Tenofovir Mycobacterium Infections Tuberculosis Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Actinomycetales Infections Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |