Anti-HIV Medications for People Recently Infected With HIV

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00106171
First received: March 21, 2005
Last updated: February 17, 2011
Last verified: February 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of HAART in Acute/Early HIV Infection

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • Comparison of the CD4 lymphocyte count in all treated vs. untreated patients [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
  • Comparison of the plasma viral load in patients treated in the acute vs. early stage of infection [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
  • Comparison of the CD4 lymphocyte count in patients treated in the acute vs. early stage of infection [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
  • Toxicity of HAART in all treated patients [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: February 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive HAART for 1 year
Drug: Highly active antiretroviral therapy (HAART)
Regimens will be assigned by investigators
No Intervention: 2
Participants will receive no treatment

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6Z2C7
Canada, Ontario
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
Toronto, Ontario, Canada, M5B IL6
Sunnybrook Health Sciences Ctr.
Toronto, Ontario, Canada, M4N 3M5 CA
Canada, Quebec
CHUM - Hotel-Dieu
Montreal, Quebec, Canada, H2W 1T8 CA
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph B. Margolick, MD, PhD Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: Joseph B. Margolick, MD, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00106171     History of Changes
Other Study ID Numbers: 1R01AI056990-01A1, 1R01-AI056990-01A1
Study First Received: March 21, 2005
Last Updated: February 17, 2011
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014