Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV

Condition(s) targeted: HIV Infections

Intervention: Emtricitabine/ tenofovir disoproxil fumarate (Drug); Lopinavir/Ritonavir (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Christine Hogan, MD, Study Chair, Affiliation: Division of Infectious Diseases, Columbia University College of Physicians and Surgeons

Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.

Official title: The SETPOINT Study - A Randomized Study of the Effect of Immediate Treatment With Potent Antiretroviral Therapy Versus Observation With Treatment as Indicated in Newly Infected HIV-1 Infected Subjects: Does Early Therapy After the Virologic Setpoint?

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome:

Log10 HIV-1 viral load

Comparison of the log10 HIV-1 viral load for each Arm A participant with the log10 HIV-1 viral load for each Arm B participant

Number of participants experiencing either a CDC category B or C diagnosis, grade 3 or 4 adverse event, treatment-limiting adverse event, or acute retroviral syndrome

Secondary outcome:

Log10 HIV-1 viral load

CD4 and CD8 cells

Number of participants meeting clinical, virologic, or immunologic criteria for treatment initiation or continuation

Time from study entry in Arm B participants or from Week 36 in Arm A participants to meeting the clinical, virologic, or immunologic criteria for treatment initiation or continuation

Number of participants off treatment

Number of participants on treatment who develop resistance to any component of the treatment regimen

Number of participants in each arm that develops major organ disease

Detailed description: Combination antiretroviral therapy has resulted in significantly decreased morbidity and mortality, incidence of opportunistic infections, and hospitalizations in HIV infected people. However, because of long-term toxicities associated with long-term use of antiretrovirals and the persistence of virus in latent reservoirs, it is unclear when it is best to initiate therapy in recently infected individuals. This study will compare the virologic outcomes of adults recently infected with HIV who receive emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), coformulated as Truvada, and lopinavir/ritonavir (LPV/RTV), coformulated as Kaletra, with those who receive no treatment.

This study will last 96 weeks. Participants will be randomly assigned to one of two groups. For the first 36 weeks of the study, Group 1 will receive FTC/TDF once daily and LPV/RTV twice daily. Some Group 1 participants will receive a different ART regimen as determined by the participant and study staff, if appropriate. Group 2 will receive no treatment for the duration of the study. At Week 37, participants from both Group 1 and 2 will be offered treatment continuation or initiation until Week 96 if they have a high viral load, low CD4 count, or are experiencing HIV-related symptoms. Study visits will occur at screening, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 37, 38, 40, and every 4 weeks thereafter. Clinical assessment and blood collection will occur at all visits. Urine tests will occur at selected visits. Participants will be asked to complete an adherence questionnaire at Weeks 12, 24, and 36.

Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria for Step 1:

- Recently infected with HIV

- CD4 count of 350 cells/mm3 or more AND a CD4% of 14% or more within 21 days prior to

study entry

- HIV viral load of 500 copies/ml or more within 21 days prior to study entry

- Ability and willingness to follow protocol requirements

- Willing to use acceptable forms of contraception

Exclusion Criteria for Step 1:

- Prior antiretroviral therapy. Participants who took antiretrovirals for postexposure

prophylaxis more than one year prior to study entry are not excluded.

- CDC category B or C HIV disease

- History of pancreatitis or coronary artery disease

- Certain medications within 21 days prior to study entry. Participants who agree to

receive an alternative ART regimen approved by the investigator will not be excluded.

- Previously received an investigational anti-HIV vaccine

- Current therapy with systemic corticosteroids. Patients who are taking a short course

(less than 21 days) of corticosteroids are not excluded.

- Current therapy with systemic chemotherapeutic agents; nephrotoxic systemic agents;

immunomodulatory treatments, including interleukin-2; or investigational agents

- Known allergy or sensitivity to study drugs or their formulations

- Current alcohol or drug use that, in the opinion of the investigator, would interfere

with the study

- Serious medical or psychiatric illness that, in the opinion of the investigator, would

interfere with the study

- Hepatitis B surface antigen positive within 21 days prior to study entry

- Known resistance to one or more components of the study drug regimen

- Pregnant or breastfeeding

University of California-San Diego, San Diego, California 92103, United States; Recruiting
Jill Kunkel, RN, Phone: 619-543-8080, Email: jkunkel@ucsd.edu

University of California-San Francisco, San Francisco, California 94110, United States; Recruiting
Paul Bradley, Phone: 415-476-9296, Ext: 318, Email: pbradley@php.ucsf.edu

Cedars-Sinai Medical Center, Culver City, California 90230, United States; Active, not recruiting

Harbor-UCLA, Culver City, California 90230, United States; Recruiting
Jacqui Pitt, RN, ACRN, Phone: 310-423-3755, Email: jpitt@rei.edu

0601 UCLA School of Medicine, CARE Ctr., Los Angeles, California 90035, United States; Active, not recruiting

University of Colorado Health Sciences Center, Denver, Colorado 80262-3706, United States; Recruiting
M. Graham Ray, RN, MSN, Phone: 303-372-5535, Email: graham.ray@uchsc.edu

University of Miami, Miami, Florida 33136-1013, United States; Recruiting
Leslie Thompson, RN, BSN, Phone: 305-243-3838, Email: lthomps@gate.net

Emory University, Atlanta, Georgia 30308, United States; Recruiting
Ericka R. Patrick, RN, Phone: 404-616-6313, Email: erpatri@emory.edu

Rush-Presbyterian/St. Lukes (Chicago), Chicago, Illinois 60612-3806, United States; Recruiting
Jan Fritsche, MS, RN, CS, Phone: 312-942-4810, Email: jfrits@rush.edu

Feinberg School of Medicine, HIV/ACTU, Chicago, Illinois 60611-3015, United States; Recruiting
Baiba Berzins, MPH, Phone: 312-695-5012, Email: baiba@northwestern.edu

Indiana University Hospital, Indianapolis, Indiana 46202-5250, United States; Recruiting
Beth Zwickl, RN,CS, MSN, Phone: 317-274-8456, Email: bwzwickl@iupui.edu

Methodist Hospital of Indiana, Indianapolis, Indiana 46202-5250, United States; Active, not recruiting

Wishard Hospital, Indianapolis, Indiana 46202, United States; Recruiting
Scott Hamilton, RN, Phone: 317-630-6023, Email: shamilt2@iupui.edu

Massachusetts General Hospital-Partners AIDS Research, Boston, Massachusetts 02114, United States; Recruiting
Mary Johnston, RN, BSN, Phone: 617-724-0070, Email: mnjohnston@partners.org

Brigham and Womens Hospital, Boston, Massachusetts 02115, United States; Recruiting
Jon Gothing, RN, BSN, ACRN, Phone: 617-732-5635, Email: jgothing@partners.org

Harvard (Massachusetts General Hospital), Boston, Massachusetts 02114, United States; Recruiting
Teri Flynn, RN, ANP, Phone: 617-724-0072, Email: tflynn@partners.org

Henry Ford Hospital AIDS Clinic, Detroit, Michigan 48202, United States; Recruiting
Linda Makohon, RN, BSN, Phone: 313-916-2570, Email: lmakoho1@hfhs.org

Washington University (St. Louis), St. Louis, Missouri 63108-2138, United States; Recruiting
Michael Klebert, RN-C, MSN, Phone: 314-454-0058, Email: mklebert@im.wustl.edu

Aaron Diamond AIDS Research Center at Rockefeller, New York, New York 10021, United States; Recruiting
Arlene Hurley, RN, MA, Phone: 212-327-7281, Email: ahurleya@adarc.org

University of Rochester Medical Center, Rochester, New York 14642-0001, United States; Recruiting
Carol Greisberger, RN, BS, Phone: 585-275-2740, Email: carol_greisberger@urmc.rochester.edu

Community Health Network, Inc., Rochester, New York 14642-0001, United States; Recruiting
Carol Greisberger, RN, BS, Phone: 585-275-2740, Email: carol_greisberger@urmc.rochester.edu

SUNY - Buffalo (Rochester), Buffalo, New York 14215, United States; Terminated

Beth Israel Medical Center, New York, New York 10003, United States; Recruiting
Ann Marshak, Phone: 212-420-4432, Email: marshakann@aol.com

Columbia University, New York, New York 10032, United States; Recruiting
Steven Chang, NP, Phone: 212-305-1570, Email: sc1286@columbia.edu

NYU/Bellevue, New York, New York 10016-6481, United States; Active, not recruiting

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Suzanne Aycock, RN, BSN, CCRC, Phone: 919-684-8216, Email: aycoc001@mc.duke.edu

University of North Carolina, Chapel Hill, North Carolina 27514, United States; Recruiting
Cheryl J. Marcus, RN, BSN, Phone: 919-843-8761, Email: cjm@med.unc.edu

The Moses H. Cone Memorial Hospital, Greensboro, North Carolina 27401-4001, United States; Recruiting
Kim Epperson, RN, Phone: 336-832-7888, Email: kimepperson@mosescone.com

Wake County Department of Health, Chapel HIll, North Carolina 27514, United States; Active, not recruiting

Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Todd L. Lusch, BA, Phone: 614-293-8112, Email: lusch-1@medctr.osu.edu

University of Pennsylvania, Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Joseph Quinn, RN, Phone: 215-349-8092, Email: joseph.quinn@uphs.upenn.edu

Presbyterian Medical Center - Univ. of PA, Philadelphia, Pennsylvania 19104, United States; Recruiting
Joseph Quinn, RN, Phone: 215-349-8092, Email: joseph.quinn@uphs.upenn.edu

The Miriam Hospital, Providence, Rhode Island 02906, United States; Recruiting
Pamela Poethke, Phone: 401-793-4971, Email: ppoethke@lifespan.org

Rhode Island Hospital, Providence, Rhode Island 02906, United States; Active, not recruiting

Stanley Street Treatment and Resource, Providence, Rhode Island 02906, United States; Active, not recruiting

University of Washington, Seattle, Seattle, Washington 98104, United States; Recruiting
Jeanne Conley, RN, BSN, Phone: 206-731-8877, Email: njc@u.washington.edu

University of Washington General Clinical Research, Seattle, Washington 98104, United States; Recruiting
Jeanne Conley, RN, BSN, Phone: 206-731-8877, Email: njc@u.washington.edu

Click here for more information about emtricitabine/ tenofovir disoproxil fumarate

Click here for more information about lopinavir/ritonavir

Click here for more information about the AIEDRP CORE01 study

Click here for more information on recommended HIV regimens

Click here for more information on starting anti-HIV medications

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Related publications:

Fidler S, Oxenius A, Brady M, Clarke J, Cropley I, Babiker A, Zhang HT, Price D, Phillips R, Weber J. Virological and immunological effects of short-course antiretroviral therapy in primary HIV infection. AIDS. 2002 Oct 18;16(15):2049-54.

Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. Epub 2004 Apr 30.

Little SJ, Holte S, Routy JP, Daar ES, Markowitz M, Collier AC, Koup RA, Mellors JW, Connick E, Conway B, Kilby M, Wang L, Whitcomb JM, Hellmann NS, Richman DD. Antiretroviral-drug resistance among patients recently infected with HIV. N Engl J Med. 2002 Aug 8;347(6):385-94.

Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. Review.

Starting date: March 2005
Ending date: December 2010
Last updated: August 7, 2008