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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Amprenavir; Efavirenz; Indinavir; Lamivudine; Lamivudine, zidovudine drug combination; Ritonavir; Vaccines; Zidovudine

Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.