|
|
|
|
|
|
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 |
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 |
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 |
Estimated Enrollment: | 180 |
Study Start Date: | February 2005 |
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Joseph B. Margolick, MD, PhD | Johns Hopkins University |
Click here for more information about starting anti-HIV medications 
  |
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 |
|
|
|
|
|