Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001119

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

288

Starts

1999-10-01

Last updated by the study team

2011-03-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• San Francisco Dept of Hlth / AIDS Office — San Francisco, California, United States
• Univ of Illinois Chicago / Howard Brown Hlth Ctr — Chicago, Illinois, United States
• Fenway Community Health Ctr / HIVNET — Boston, Massachusetts, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• New York Univ Med Ctr — New York, New York, United States
• Bronx-Lebanon Hosp Ctr — The Bronx, New York, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Mem Hosp of Rhode Island — Pawtucket, Rhode Island, United States
• Seattle HIVNET — Seattle, Washington, United States
• Univ of Washington — Seattle, Washington, United States
• Fred Hutchinson Cancer Research Ctr — Seattle, Washington, United States
• Saint Vincent's Hosp Med Centre — Darlinghurst, Australia

Full record on ClinicalTrials.gov

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