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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Current treatment guidelines recommend combination ART for acute primary HIV-1 infection. However, it is not known whether ART given during acute infection delays progression to AIDS or improves survival rates. Preliminary studies suggest ART given early in HIV infection not only reduces viral load but also restricts CD4+ cell loss, delays the development of opportunistic infections, and preserves T-helper cells and naive T cells. The immunologic basis of these protective effects has not been characterized thoroughly. This protocol assesses ART's effects on immune responses in early HIV inf...

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Eligibility 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.