Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV

Acute, primary HIV infection represents a potentially unique opportunity to eradicate the
infection. Although plasma viral load rises rapidly, the dominant infecting virus is
relatively uniform genetically, and infection may not be fully established in all tissue
sites until some time after exposure. Current antiretroviral therapy is able to reduce
plasma viral load to unmeasurable levels in established infection. However, there are many
questions that remain about the treatment of primary HIV infection. While it is assumed that
aggressive antiretroviral regimens are required, it is not known how long they must be
continued. It is hoped that after an interval of aggressive therapy, the number of agents
could be safely reduced. This study evaluates if viral suppression can be sustained after
study therapy is withdrawn.

Participants in this study will receive lamivudine (3TC), stavudine (d4T), abacavir (ABC),
amprenavir (APV), and ritonavir (RTV) for at least 52 weeks. During this induction phase,
participants will be followed through regular study visits every 4 or 8 weeks. If the
participant's viral load and CD4 counts are within study parameters at the end of 52 weeks,
the participant will discontinue all antiretroviral medications simultaneously. Participants
in the treatment interruption phase will be followed weekly initially, every 2 weeks for 8
weeks, and then every 4 or 8 weeks. Treatment may be restarted if necessary during this
phase based on viral load and CD4 counts. If treatment is restarted, the participant will
receive 3TC, d4T, APV, and RTV but not ABC. During this reinduction phase, participants will
be followed every 4 or 8 weeks.

Depending on viral load and CD4 counts, participants may be eligible for a second treatment
interruption phase following the reinduction phase. Participants will once again stop all
antiretroviral medications simultaneously and will have the same monitoring as in the first
treatment interruption phase. Following this second treatment interruption, participants
will be restarted on 3TC, d4T, APV, and RTV and will be evaluated at Weeks 4, 8, 16, and 24,
at which time participants go off study.

The length of study participation for individual participants will vary. The length of each
phase will be highly dependent on the participant's laboratory parameters. In general,
participants will be enrolled in the study for 3 to 4 years. Participants may also enroll in
immunology, compartment, pharmacology, and medication compliance substudies.

Inclusion Criteria:

- Acute HIV infection (recently infected with HIV or recent seroconversion)

- Karnofsky status of 80 or greater within 14 days prior to study entry

- Acceptable methods of contraception

- Able and willing to give written informed consent

Exclusion Criteria:

- Previously received anti-HIV drugs

- Hepatitis within 30 days prior to study entry

- Pancreatitis within 120 days prior to study entry

- Radiation or chemotherapy within 30 days prior to study entry

- Certain medications within 14 days prior to study entry

- Experimental or investigational therapy within 30 days prior to study entry

- Illness (non-HIV infection, cancer, etc.) at the time of study entry

- Pregnant or breastfeeding