Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
A Study of the Effects of Combination Antiretroviral Therapy in Acute HIV-1 Infection With an Emphasis on Immunological Responses
1 other identifier
interventional
288
2 countries
12
Brief Summary
The purpose of this study is to find out whether these powerful combinations of anti-HIV drugs are safe and effective for use in patients in the early stages of HIV infection and to find out how patients' immune systems react to HIV and anti-HIV drugs. Doctors generally treat patients in the early stages of HIV infection with the same anti-HIV drugs taken by patients who have had HIV for a long time. These drugs lower the level of HIV in the blood. However, doctors do not know whether patients who take anti-HIV drugs in the early stages of HIV infection actually live longer or have fewer AIDS-related diseases. This study will help doctors answer these questions. In the main study, doctors will look at how 2 different anti-HIV drug combinations affect the immune system. In the 2 substudies, doctors will look at how the body reacts to the hepatitis B vaccine and the tetanus vaccine. These substudies may help doctors learn how HIV-infected patients respond to new infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedMarch 2, 2011
January 1, 2005
4.7 years
November 2, 1999
March 1, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for the main study if they:
- Became infected with HIV within the last 120 days.
- Are at least age 16 and have written consent of a parent or guardian if under 18.
- Are willing to practice abstinence or use barrier methods of birth control, such as condoms.
- Are available for at least 72 weeks.
- Patients may be eligible for 1 of the 2 substudies if they:
- Are at least age 16 and have written consent of a parent or guardian if under 18.
- Have had HIV infection for more than 1 year and have a CD4 cell count greater than 500 cells/mm3, or do not have HIV infection but are at risk of getting HIV because of their lifestyle, such as sexual activity or injection drug use.
- Have never had hepatitis B infection or a hepatitis B vaccine and they are available for 28 weeks (hepatitis B vaccine substudy only).
- Have not received a tetanus shot in the past 5 years, have never had an allergic reaction to a tetanus shot, and are available for 8 weeks (tetanus shot substudy only).
You may not qualify if:
- Patients will not be eligible for the main study if they:
- Have taken anti-HIV drugs for more than 7 days for the treatment of HIV. However, anti-HIV drugs taken to help prevent HIV are acceptable.
- Have certain types of cancer.
- Are receiving an experimental treatment.
- Are pregnant or breast-feeding.
- Are allergic to study drugs.
- Have taken certain medications that may interfere with the study.
- Patients will not be eligible for 1 of the 2 substudies if they:
- Are receiving an experimental treatment.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102, United States
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, 60612, United States
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, 02115, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
New York Univ Med Ctr
New York, New York, 10016, United States
Bronx-Lebanon Hosp Ctr
The Bronx, New York, 10453, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Seattle HIVNET
Seattle, Washington, 98104, United States
Univ of Washington
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Ctr
Seattle, Washington, 98109, United States
Saint Vincent's Hosp Med Centre
Darlinghurst, Australia
Related Publications (1)
Stekler J, Maenza J, Stevens C, Holte S, Malhotra U, McElrath MJ, Corey L, Collier AC. Abacavir hypersensitivity reaction in primary HIV infection. AIDS. 2006 Jun 12;20(9):1269-74. doi: 10.1097/01.aids.0000232234.19006.a2.
PMID: 16816555RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lawrence Corey