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Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000940
  Purpose

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

MedlinePlus related topics: AIDS AIDS Medicines
Drug Information available for: Abacavir Abacavir sulfate Lamivudine Stavudine Ritonavir VX 478
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial to Evaluate the Safety and Efficacy of Induction Treatment With Lamivudine Plus Stavudine Plus Abacavir Plus Amprenavir/Ritonavir Followed by Supervised Treatment Interruption in Subjects With Acute HIV Infection or Recent Seroconversion

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 121
Study Start Date: March 1997
Study Completion Date: October 2006
Detailed Description:

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 This study evaluates if viral suppression can be sustained after study therapy is withdrawn.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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000940

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

Click here for more information about stavudine.  This link exits the ClinicalTrials.gov site
Click here for more information about lamivudine.  This link exits the ClinicalTrials.gov site
Click here for more information about ritonavir.  This link exits the ClinicalTrials.gov site
Click here for more information about abacavir sulfate.  This link exits the ClinicalTrials.gov site
Click here for more information about amprenavir.  This link exits the ClinicalTrials.gov site
Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site

Publications:
Ait-Khaled M, Rakik A, Griffin P, Cutrell A, Fischl MA, Clumeck N, Greenberg SB, Rubio R, Peters BS, Pulido F, Gould J, Pearce G, Spreen W, Tisdale M, Lafon S; CNA3003 International Study Team. Mutations in HIV-1 reverse transcriptase during therapy with abacavir, lamivudine and zidovudine in HIV-1-infected adults with no prior antiretroviral therapy. Antivir Ther. 2002 Mar;7(1):43-51.
Garcia F, Plana M, Mestre G, Arnedo M, Gil C, Miro JM, Cruceta A, Pumarola T, Gallart T, Gatell JM. Immunological and virological factors at baseline may predict response to structured therapy interruption in early stage chronic HIV-1 infection. AIDS. 2002 Sep 6;16(13):1761-5.
Garcia F, Plana M, Ortiz GM, Bonhoeffer S, Soriano A, Vidal C, Cruceta A, Arnedo M, Gil C, Pantaleo G, Pumarola T, Gallart T, Nixon DF, Miro JM, Gatell JM. The virological and immunological consequences of structured treatment interruptions in chronic HIV-1 infection. AIDS. 2001 Jun 15;15(9):F29-40.
Mira JA, Macias J, Nogales C, Fernandez-Rivera J, Garcia-Garcia JA, Ramos A, Pineda JA. Transient rebounds of low-level viraemia among HIV-infected patients under HAART are not associated with virological or immunological failure. Antivir Ther. 2002 Dec;7(4):251-6.
Tilling R, Kinloch S, Goh LE, Cooper D, Perrin L, Lampe F, Zaunders J, Hoen B, Tsoukas C, Andersson J, Janossy G; Quest Study Group. Parallel decline of CD8+/CD38++ T cells and viraemia in response to quadruple highly active antiretroviral therapy in primary HIV infection. AIDS. 2002 Mar 8;16(4):589-96.

Study ID Numbers: ACTG 371, ACTG 710 (substudy), ACTG 711 (substudy), ACTG 729 (substudy), ACTG 709 (substudy), AACTG 371
Study First Received: November 2, 1999
Last Updated: September 26, 2008
ClinicalTrials.gov Identifier: NCT00000940  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Stavudine
Amprenavir/Ritonavir
Protease Inhibitors
Lamivudine
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Abacavir Sulfate
Acute Infection
Treatment Interruption

Study placed in the following topic categories:
Virus Diseases
Amprenavir
Sexually Transmitted Diseases, Viral
Stavudine
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Abacavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Antibiotics, Antitubercular
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009