Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Immunity, Cellular, Drug Therapy, Combination, HIV Protease Inhibitors, Antibody Formation, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Tetanus Toxoid, Case-Control Studies, Hepatitis B Surface Antigens, Acute Infection
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.
Sites / Locations
- San Francisco Dept of Hlth / AIDS Office
- Univ of Illinois Chicago / Howard Brown Hlth Ctr
- Fenway Community Health Ctr / HIVNET
- Univ of Minnesota
- Bronx-Lebanon Hosp Ctr
- New York Univ Med Ctr
- Univ of Cincinnati
- Mem Hosp of Rhode Island
- Seattle HIVNET
- Univ of Washington
- Fred Hutchinson Cancer Research Ctr
- Saint Vincent's Hosp Med Centre