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

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Adult AIDS Clinical Trials Group
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00090779

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Emtricitabine/ tenofovir disoproxil fumarate Drug: Lopinavir/Ritonavir

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Lopinavir Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Study Type:

Interventional

Study Design:

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

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?

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Log10 HIV-1 viral load [ Time Frame: At Weeks 72 and 76 ] [ Designated as safety issue: No ]
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 [ Time Frame: At Weeks 72, 76, 36, and 40 ] [ Designated as safety issue: No ]
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 [ Time Frame: At Week 96 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Log10 HIV-1 viral load [ Time Frame: At Weeks 36 and 96 ] [ Designated as safety issue: No ]
CD4 and CD8 cells [ Time Frame: At Weeks 36, 72, and 96 ] [ Designated as safety issue: No ]
Number of participants meeting clinical, virologic, or immunologic criteria for treatment initiation or continuation [ Time Frame: Throuhgout study ] [ Designated as safety issue: No ]
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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Number of participants off treatment [ Time Frame: At Week 96 ] [ Designated as safety issue: No ]
Number of participants on treatment who develop resistance to any component of the treatment regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Number of participants in each arm that develops major organ disease [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

150

Study Start Date:

March 2005

Estimated Study Completion Date:

December 2010

Estimated Primary Completion Date:

December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Group 1 will receive emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily	Drug: Emtricitabine/ tenofovir disoproxil fumarate once daily Drug: Lopinavir/Ritonavir twice daily
2: No Intervention No Treatment

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.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090779

Show 38 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Adult AIDS Clinical Trials Group

Investigators

Study Chair:

Christine Hogan, MD

Division of Infectious Diseases, Columbia University College of Physicians and Surgeons

More Information

Click here for more information about emtricitabine/ tenofovir disoproxil fumarate This link exits the ClinicalTrials.gov site

Click here for more information about lopinavir/ritonavir This link exits the ClinicalTrials.gov site

Click here for more information about the AIEDRP CORE01 study This link exits the ClinicalTrials.gov site

Click here for more information on recommended HIV regimens This link exits the ClinicalTrials.gov site

Click here for more information on starting anti-HIV medications This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español This link exits the ClinicalTrials.gov site

Publications of Results:

Messer K, Vaida F, Hogan C. Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217. Contemp Clin Trials. 2006 Jul 25; [Epub ahead of print]

Other 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.

Responsible Party:

DAIDS ( Rona Siskind )

Study ID Numbers:

ACTG A5217, AIEDRP AIN503, ACTG A5217

First Received:

September 3, 2004

Last Updated:

December 12, 2008

ClinicalTrials.gov Identifier:

NCT00090779

Health Authority:

United States: Federal Government

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

Acute Infection
Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
Emtricitabine
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Tenofovir
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:

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
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 07, 2009