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

March 21, 2005
February 17, 2011
February 2005
April 2009   (final data collection date for primary outcome measure)
Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]
Comparison of the plasma viral load 24 months after initial presentation in all treated vs. untreated patients
Complete list of historical versions of study NCT00106171 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Anti-HIV Medications for People Recently Infected With HIV
A Randomized Trial of HAART in Acute/Early HIV Infection

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Highly active antiretroviral therapy (HAART)
Regimens will be assigned by investigators
  • Experimental: 1
    Participants will receive HAART for 1 year
    Intervention: Drug: Highly active antiretroviral therapy (HAART)
  • No Intervention: 2
    Participants will receive no treatment
Smith DE, Walker BD, Cooper DA, Rosenberg ES, Kaldor JM. Is antiretroviral treatment of primary HIV infection clinically justified on the basis of current evidence? AIDS. 2004 Mar 26;18(5):709-18. Review. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00106171
1R01AI056990-01A1, 1R01-AI056990-01A1
Not Provided
Joseph B. Margolick, MD, PhD, Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Joseph B. Margolick, MD, PhD Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
February 2011

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