This study will determine what effect taking a combination of five anti-HIV drugs during the early stage of HIV infection, then temporarily stopping them once or twice, may have on the amount of HIV virus in the blood (viral load). The study will also evaluate the safety and effectiveness of this anti-HIV drug combination.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Ritonavir  Drug: Abacavir sulfate  Drug: Amprenavir  Drug: Lamivudine  Drug: Stavudine	Phase II

Further Study Details: 

Expected Total Enrollment:  121

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 This study evaluates if viral suppression can be sustained after study therapy is withdrawn.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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

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

California
      Univ of California / San Diego Treatment Ctr, San Diego,  California,  921036325,  United States
      San Francisco Gen Hosp, San Francisco,  California,  941102859,  United States
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States
      Univ of Southern California / LA County USC Med Ctr, Los Angeles,  California,  900331079,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States
Hawaii
      Univ of Hawaii, Honolulu,  Hawaii,  96816,  United States
Massachusetts
      Harvard (Massachusetts Gen Hosp), Boston,  Massachusetts,  02114,  United States
Missouri
      Washington Univ (St. Louis), St. Louis,  Missouri,  63108-2138,  United States
New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Cornell Univ Med Ctr, New York,  New York,  10021,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
      Chelsea Ctr, New York,  New York,  10021,  United States
      St Mary's Hosp (Univ of Rochester/Infectious Diseases), Rochester,  New York,  14642,  United States
      Community Health Network Inc, Rochester,  New York,  14642,  United States
North Carolina
      Univ of North Carolina, Chapel Hill,  North Carolina,  27514,  United States
Pennsylvania
      Univ of Pennsylvania at Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Presbyterian Med Ctr- Univ of PA, Norristown,  Pennsylvania,  19401,  United States
Rhode Island
      Miriam Hosp / Brown Univ, Providence,  Rhode Island,  02906,  United States
Puerto Rico
      Univ of Puerto Rico, San Juan,  009365067,  Puerto Rico

Study chairs or principal investigators

Paul Volberding, MD,  Study Chair,  San Francisco Veterans Medical Center   
Elizabeth Connick, MD,  Study Chair,  Infectious Disease Division, University of Colorado Health Sciences Center   

Study ID Numbers:  ACTG 371; ACTG 710 (substudy); ACTG 711 (substudy); ACTG 729 (substudy); ACTG 709 (substudy); AACTG 371
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000940
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08