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

NCT00000940 | Completed Phase 2

• 7 other identifiers: ACTG 37110099ACTG 710 (substudy)ACTG 711 (substudy)ACTG 729 (substudy)ACTG 709 (substudy)AACTG 371
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

HIV Infections

Keywords

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

Interventions

Ritonavir DRUG

Abacavir sulfate DRUG

Amprenavir DRUG

Lamivudine DRUG

Stavudine DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (18)

USC CRS

Los Angeles, California, 90033, United States

Location

UCLA CARE Center CRS

Los Angeles, California, 90035, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80045, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

SSTAR, Family Healthcare Ctr.

Fall River, Massachusetts, 02720, United States

Location

Washington U CRS

St Louis, Missouri, 63110, United States

Location

Beth Israel Med. Ctr. ACTU

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Columbia P&S CRS

New York, New York, 10032, United States

Location

AIDS Care CRS

Rochester, New York, 14607, United States

Location

McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit

Rochester, New York, 14642, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27514, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, 02906, United States

Location

Related Publications (7)

• 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.

  PMID: 12008787 BACKGROUND

• 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. doi: 10.1097/00002030-200209060-00008.

  PMID: 12218387 BACKGROUND

• 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. doi: 10.1097/00002030-200106150-00002.

  PMID: 11416735 BACKGROUND

• 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. doi: 10.1177/135965350200700404.

  PMID: 12553479 BACKGROUND

• 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. doi: 10.1097/00002030-200203080-00010.

  PMID: 11873002 BACKGROUND

• Volberding P, Demeter L, Bosch RJ, Aga E, Pettinelli C, Hirsch M, Vogler M, Martinez A, Little S, Connick E; ACTG 371 Team. Antiretroviral therapy in acute and recent HIV infection: a prospective multicenter stratified trial of intentionally interrupted treatment. AIDS. 2009 Sep 24;23(15):1987-95. doi: 10.1097/QAD.0b013e32832eb285.

  PMID: 19696651 RESULT

• Connick E, Bosch RJ, Aga E, Schlichtemeier R, Demeter LM, Volberding P; ACTG 709 Team. Augmented HIV-specific interferon-gamma responses, but impaired lymphoproliferation during interruption of antiretroviral treatment initiated in primary HIV infection. J Acquir Immune Defic Syndr. 2011 Sep 1;58(1):1-8. doi: 10.1097/QAI.0b013e318224d0c7.

  PMID: 21637110 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Ritonavir; abacavir; amprenavir; Lamivudine; Stavudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Officials

• Paul Volberding, MD

  San Francisco Veterans Medical Center

  STUDY CHAIR

• Elizabeth Connick, MD

  Infectious Disease Division, University of Colorado Health Sciences Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: May 1, 1999
• Study Completion: October 1, 2006
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (18)