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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000940
First received: November 2, 1999
Last updated: May 17, 2012
Last verified: May 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Enrollment: 121
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 This study evaluates if viral suppression can be sustained after study therapy is withdrawn.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000940

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
USC CRS
Los Angeles, California, United States, 90033
Ucsd, Avrc Crs
San Diego, California, United States, 92103
Ucsf Aids Crs
San Francisco, California, United States, 94110
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
United States, Hawaii
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
United States, Massachusetts
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
SSTAR, Family Healthcare Ctr.
Fall River, Massachusetts, United States, 02720
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States, 63110
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Beth Israel Med. Ctr. ACTU
New York, New York, United States, 10003
HIV Prevention & Treatment CRS
New York, New York, United States, 10032
AIDS Care CRS
Rochester, New York, United States, 14607
McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
Rochester, New York, United States, 14642
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States, 02906
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

Additional Information:
Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000940     History of Changes
Other Study ID Numbers: ACTG 371, 10099, ACTG 710 (substudy), ACTG 711 (substudy), ACTG 729 (substudy), ACTG 709 (substudy), AACTG 371
Study First Received: November 2, 1999
Last Updated: May 17, 2012
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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Amprenavir
Lamivudine
Abacavir
Stavudine
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014