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Anti-HIV Medications for People Recently Infected With HIV

This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), July 2007

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00106171
  Purpose

It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV.

Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.


Condition Intervention Phase
HIV Infections
Drug: Highly active antiretroviral therapy (HAART)
Phase IV

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized Trial of HAART in Acute/Early HIV Infection

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

Primary Outcome Measures:
  • Comparison of the plasma viral load 24 months after initial presentation in all treated vs. untreated patients

Secondary Outcome Measures:
  • Comparison of the plasma viral load 36 months after initial presentation in all treated vs. untreated patients
  • comparison of the CD4 lymphocyte count 24 and 36 months after initial presentation in all treated vs. untreated patients
  • comparison of the plasma viral load 24 and 36 months after initial presentation in patients treated in the acute vs. early stage of infection
  • comparison of the CD4 lymphocyte count 24 and 36 months after initial presentation in patients treated in the acute vs. early stage of infection
  • toxicity of HAART in all treated patients

Estimated Enrollment:   180
Study Start Date:   February 2005

Detailed Description:

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 slower progression of HIV disease. This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy (HAART) with those who receive no treatment. This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion (acute seroconverters) with patients who enroll within 3 to 12 months of seroconversion (early seroconverters).

This study will last at least 3 years. Participants will be randomly assigned to one of two groups. Group 1 will receive HAART for 1 year; Group 2 will receive no treatment. There will be at least 20 study visits over the 3-year study period. Blood collection will occur at all study visits. A physical exam, medical and medication history, and risk behavior assessment will occur at most visits; participants will also be asked to complete an adherence questionnaire at most visits.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Documented acute or recent HIV infection (infected in the past 12 months) as defined in the study protocol
  • Antiretroviral naive. Participants who have taken antiretrovirals for postexposure prophylaxis are eligible for this study.
  • Able to swallow tablets or capsules
  • Willing to use acceptable forms of contraception

Exclusion Criteria:

  • Physician unable to design a potentially effective HAART regimen based on results of genotypic resistance testing
  • Two CD4 counts of less than 350 cells/mm3 obtained at least 7 days apart within 30 days of study entry
  • Viral load less than 5,000 copies/ml within 30 days of study entry in participants who have been infected with HIV-1 for more than six months prior to study entry
  • Use of systemic cancer chemotherapy, systemic investigational agents, specific antiretroviral medications, or immunomodulators (growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons) within 30 days prior to study entry
  • Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study
  • Serious illness requiring systemic treatment or hospitalization until participant either completes therapy or is clinically stable on therapy for at least 7 days prior to study entry
  • Currently involuntarily incarcerated for treatment of either a psychiatric or physical (e.g., infectious disease) illness
  • Pregnancy or breastfeeding
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106171

Locations
United States, Maryland
Johns Hopkins University     Recruiting
      Baltimore, Maryland, United States, 21205
      Contact: Linda G. Apuzzo, BS/CCRC     410-614-7796     lapuzzo@jhsph.edu    
      Principal Investigator: Joseph B. Margolick, MD, PhD            
Canada, British Columbia
University of British Columbia     Recruiting
      Vancouver, British Columbia, Canada, V6Z2C7
      Contact: Jennie Prasad, MS     604-642-6429     jenniepd@interchange.ubc.ca    
      Principal Investigator: Brian Conway, MD, FRCPC            
Canada, Ontario
Sunnybrook Health Sciences Ctr.     Recruiting
      Toronto, Ontario, Canada, M4N 3M5 CA
      Contact: Miriam Bast     416-480-5900     mriam.bast@ssunnybrook.ca    
      Principal Investigator: Anita Rachlis, MD            
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.     Recruiting
      Toronto, Ontario, Canada, M5B IL6
      Contact: Mona Loutify, MD     (416) 465-7936     loutify@schospital.ca    
      Principal Investigator: Colin Kovacs, MD            
Canada, Quebec
CHUM - Hotel-Dieu     Recruiting
      Montreal, Quebec, Canada, H2W 1T8 CA
      Contact: Genevieve Bujold     514-890-9000     genevieve.bujold.chum@ssss.gouv.qc.ca    
      Principal Investigator: Cecile Tremblay, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Joseph B. Margolick, MD, PhD     Johns Hopkins University    
  More Information


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

Publications:

Study ID Numbers:   1R01AI056990-01A1, 1R01-AI056990-01A1
First Received:   March 21, 2005
Last Updated:   November 21, 2007
ClinicalTrials.gov Identifier:   NCT00106171
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV  
Acute/Early Seroconverters  
Acute Infection  
Treatment Naive  
Primary HIV Infection  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on September 23, 2008




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