A Randomized Study of Treatment with Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) and Two Protease Inhibitors (PI) Versus no therapy in Newly Infected HIV-1 Infected Subjects to Determine Whether Potent Antiretroviral Therapy Alters the Virologic Setpoint.

The study is being done to learn if treating people during early HIV infection is beneficial. This study will evaluate how safe and effective a combination of anti-HIV drugs is for people with recently acquired HIV infection. It is known that combination anti-HIV drugs decreases the amount of virus in the blood (viral load) and improve the immune system. However, these drugs also have short-term and long-term side effects that must be considered when people decide whether or not to begin anti-HIV medicine.  The drugs used in this study have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of people with chronic HIV infection.

• Men and women who are at least 18 years old
• Early HIV-1 infection
• CD4+ cell count 350 cells/mm³ or more obtained within 21 days prior to study entry
• HIV-1 RNA 500 copies/mL or greater obtained within 21 days prior to study entry