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

Further Study Details: 

Primary Outcomes: Comparison of the plasma viral load 24 months after initial presentation in all treated vs. untreated patients
Secondary Outcomes: 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
Expected Total Enrollment:  180

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21205,  United States; Recruiting
Canada, British Columbia
      University of British Columbia, Vancouver,  British Columbia,  V6Z2C7,  Canada; Recruiting

Study chairs or principal investigators

Joseph B. Margolick, MD, PhD,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  1R01-AI056990-01A1
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  March 21, 2005
ClinicalTrials.gov Identifier:  NCT00106171
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08