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Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00414518
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : February 20, 2013
Last Update Posted : February 20, 2013
Information provided by (Responsible Party):

December 19, 2006
December 21, 2006
September 6, 2012
February 20, 2013
February 20, 2013
January 2007
February 2010   (Final data collection date for primary outcome measure)
  • Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms [ Time Frame: At Week 24 ]
  • Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome [ Time Frame: At Week 24 ]
  • Viral Set Point [ Time Frame: Throughout study ]
    set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus
  • Plasma HIV-1 viral load at Week 24 as compared between the two arms
  • number of participants experiencing either an AIDS-defining event, a Grade 3 or 4 adverse event, or acute retroviral syndrome by Week 24 as compared between the two arms
  • viral set point as compared between the two arms
Complete list of historical versions of study NCT00414518 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
An Open-Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Short Course Antiretroviral Therapy for Acute or Recent HIV-1 Infection in Zimbabwe and the United States
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators.

About 6 months after infection, HIV viral load reaches a temporarily stable level known as virus set point. Virus set point is different for each patient and can be a predictor for disease progression. Preliminary studies indicate that early, short-term antiretroviral therapy (ART) given to people newly infected with HIV may lead to lower virus set points and preserved CD4 counts. However, the length of short-term treatment needed to balance the possible adverse effects of ART with the achievement of lower virus set point is not yet known. By lowering the virus set point and maintaining CD4 counts, the need for long-term ART may be postponed. The purpose of this study is to determine the safety and efficacy of a short course of ART on producing a lower virus set point in adults recently infected with HIV.

This study will last at least 28 weeks. Participants will be randomly assigned to one of two arms. Arm A will receive ART for 12 weeks as emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) daily and lopinavir/ritonavir (LPV/RTV) in tablet form twice daily. After 12 weeks, treatment will be interrupted unless the CD4 count is measured to be less than 350 cells/mm^3 on two consecutive occasions during treatment interruption. If that occurs therapy will be resumed. Participants in Arm B will receive no treatment until cluster of differentiation 4 (CD4) counts drop below 350 cells/mm^3, indicating ART is needed. Study visits will occur at study entry, at Weeks 2 and 4, and every 4 weeks thereafter. At each study visit, a physical exam, blood collection, and completion of an adherence questionnaire will occur. Participants are encouraged to enroll in a related substudy that will evaluate HIV viral load in genital secretions.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • Drug: Tenofovir disoproxil fumarate/Emtricitabine
    300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily
    Other Name: TDF/FTC
  • Drug: Lopinavir/Ritonavir
    Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily
    Other Name: LPV/RTV
  • Experimental: Treatment interruption
    Oral Tenofovir disoproxil fumarate/Emtricitabine and Lopinavir/Ritonavir for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
    • Drug: Tenofovir disoproxil fumarate/Emtricitabine
    • Drug: Lopinavir/Ritonavir
  • Experimental: CD4 T cell guided therapy
    Anti Retroviral Therapy initiated when AIDS-defining illness occurs or if CD4 count is confirmed at less than 350 mm^3 at two separate, consecutive measurements
    • Drug: Tenofovir disoproxil fumarate/Emtricitabine
    • Drug: Lopinavir/Ritonavir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute or recent HIV-1 infection. More information about this criterion can be found in the protocol.
  • CD4 count 500 cells/mm3 or greater
  • No evidence of prior or current AIDS-defining illness
  • No signs or symptoms of HIV infection or AIDS-defining illness that, in the opinion of the investigator, requires ART
  • Willing to use acceptable forms of contraception

Exclusion Criteria:

  • Prior treatment with any antiretroviral drug for more than 7 days
  • Use of certain drugs within 21 days of study entry
  • Prior receipt of investigational anti-HIV-1 vaccine
  • Ongoing therapy with systemic corticosteroids, chemotherapeutic agents, nephrotoxic systemic agents, immunomodulatory treatments, or investigational agents
  • Known allergy/sensitivity to study drugs or their formulations
  • Current drug or alcohol use or abuse that, in the opinion of the investigator, may interfere with the study
  • Serious medical or psychiatric illness that may interfere with the study
  • Hepatitis B infected
  • Pregnancy or breastfeeding
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States,   Zimbabwe
P01AI055356 ( U.S. NIH Grant/Contract )
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University of Colorado, Denver
University of Colorado, Denver
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Michelle A. Barron, MD Division of Infectious Disease, University of Colorado Health Sciences Center
Study Chair: Margaret Borok, MRCP Department of Medicine, University of Zimbabwe
University of Colorado, Denver
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP