A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients

NCT00001084 | Completed Phase 2

• 2 other identifiers: ACTG 34311314
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 45

Brief Summary

To compare the proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels \[AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive assay\] among the 3 regimens during the maintenance phase. The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic function and delay the development of HIV-related complications. In patients administered potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and below the level of detection of commercially available assays. This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen. The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens.

Conditions

HIV Infections

Keywords

Prospective Studies; Drug Therapy, Combination; Zidovudine; HIV Protease Inhibitors; Lamivudine; Indinavir; RNA, Viral; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Interventions

Indinavir sulfate DRUG

Lamivudine DRUG

Stavudine DRUG

Zidovudine DRUG

Eligibility Criteria

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

You may qualify if:

• Patients must have:
• Documented HIV infection.
• A CD4 cell count \>= 200 cells/mm3 within 90 days prior to study entry.
• Plasma HIV RNA \>= 1000 copies/ml within 90 days prior to study entry.

You may not qualify if:

• Co-existing Condition:
• Patients with any of the following conditions or symptoms are excluded:
• A malignancy that requires systemic chemotherapy.
• Concurrent Medication:
• Excluded:
• Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed).
• All antiretroviral therapies other than study medications.
• Rifabutin and rifampin.
• Investigational drugs and vaccines.
• Systemic cytotoxic chemotherapy.
• Interferon, interleukins, GM-CSF and HIV vaccines.
• Patients with any of the following prior conditions are excluded:
• Unexplained temperature \> 38.5 degrees C for any 7 days within 30 days prior to study entry.
• Chronic diarrhea as defined as \> 3 liquid stools per day persisting for 15 days within 30 days prior to study entry.
• Proven or suspected acute hepatitis within 30 days prior to study entry, even if AST and ALT are \<= 5.0 X ULN (upper limit of normal).

Sponsors & Collaborators

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

Study Sites (45)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, 94115, United States

Location

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, 951282699, United States

Location

San Mateo AIDS Program / Stanford Univ

Stanford, California, 943055107, United States

Location

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Harbor UCLA Med Ctr

Torrance, California, 90502, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Emory Univ

Atlanta, Georgia, 30308, United States

Location

Queens Med Ctr

Honolulu, Hawaii, 96816, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, 46202, United States

Location

Univ of Iowa Hosp and Clinic

Iowa City, Iowa, 52242, United States

Location

Tulane Med Ctr Hosp

New Orleans, Louisiana, 70112, United States

Location

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

State of MD Div of Corrections / Johns Hopkins Univ Hosp

Baltimore, Maryland, 212052196, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess - West Campus

Boston, Massachusetts, 02215, United States

Location

Hennepin County Med Clinic

Minneapolis, Minnesota, 55415, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St Paul Ramsey Med Ctr

Saint Paul, Minnesota, 55101, United States

Location

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, 63112, United States

Location

Univ of Nebraska Med Ctr

Omaha, Nebraska, 681985130, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Saint Clare's Hosp and Health Ctr

New York, New York, 10019, United States

Location

Mem Sloan - Kettering Cancer Ctr

New York, New York, 10021, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Carolinas Med Ctr

Charlotte, North Carolina, 28203, United States

Location

Moses H Cone Memorial Hosp

Greensboro, North Carolina, 27401, United States

Location

Univ of Cincinnati

Cincinnati, Ohio, 452670405, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

MetroHealth Med Ctr

Cleveland, Ohio, 441091998, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Texas Galveston

Galveston, Texas, 775550435, United States

Location

Univ of Washington

Seattle, Washington, 981224304, United States

Location

Related Publications (10)

• Havlir DV, Marschner IC, Hirsch MS, Collier AC, Tebas P, Bassett RL, Ioannidis JP, Holohan MK, Leavitt R, Boone G, Richman DD. Maintenance antiretroviral therapies in HIV-infected subjects with undetectable plasma HIV RNA after triple-drug therapy. AIDS Clinical Trials Group Study 343 Team. N Engl J Med. 1998 Oct 29;339(18):1261-8. doi: 10.1056/NEJM199810293391801.

  PMID: 9791141 BACKGROUND

• Bowersox J. ACTG 343: three drugs better than two for maintaining HIV suppression. NIAID AIDS Agenda. 1998 Mar:1-2, 10-1.

  PMID: 11365088 BACKGROUND

• Maenza JR. ACTG 343: (why) we can't relax our grip on viral suppression. Hopkins HIV Rep. 1998 May;10(3):10.

  PMID: 11365491 BACKGROUND

• O'Brien TR, McDermott DH, Ioannidis JP, Carrington M, Murphy PM, Havlir DV, Richman DD. Effect of chemokine receptor gene polymorphisms on the response to potent antiretroviral therapy. AIDS. 2000 May 5;14(7):821-6. doi: 10.1097/00002030-200005050-00008.

  PMID: 10839590 BACKGROUND

• Zhou XJ, Havlir DV, Richman DD, Acosta EP, Hirsch M, Collier AC, Tebas P, Sommadossi JP; AIDS Clinical Trials Study 343 Investigators. Plasma population pharmacokinetics and penetration into cerebrospinal fluid of indinavir in combination with zidovudine and lamivudine in HIV-1-infected patients. AIDS. 2000 Dec 22;14(18):2869-76. doi: 10.1097/00002030-200012220-00008.

  PMID: 11153668 BACKGROUND

• Havlir DV, Bassett R, Levitan D, Gilbert P, Tebas P, Collier AC, Hirsch MS, Ignacio C, Condra J, Gunthard HF, Richman DD, Wong JK. Prevalence and predictive value of intermittent viremia with combination hiv therapy. JAMA. 2001 Jul 11;286(2):171-9. doi: 10.1001/jama.286.2.171.

  PMID: 11448280 BACKGROUND

• Seth A, Markee J, Ap S, Sevin A, Hoering A, Hirsch M, Collier A, Letvin N, McElrath MJ. Alterations in T cell phenotype and antigen-specific cytotoxicity in patients receiving three anti-retroviral agents (ACTG protocol 343). Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:132 (abstract no 340)

  BACKGROUND

• Havlir DV, Hirsch M, Collier A, Marschner I, Bassett R, Tebas P, Ioannidis J, Richman DD. Randomized trial of indinavir (IDV) vs. zidovudine (ZDV)/lamivudine (3TC) vs IDV/ZDV/3TC maintenance therapy after induction IDV/ZDV/3TC therapy. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:225 (abstract no LB16)

  BACKGROUND

• Gunthard HF, Havlir DV, Fiscus S, Zhang ZQ, Eron J, Mellors J, Gulick R, Frost SD, Brown AJ, Schleif W, Valentine F, Jonas L, Meibohm A, Ignacio CC, Isaacs R, Gamagami R, Emini E, Haase A, Richman DD, Wong JK. Residual human immunodeficiency virus (HIV) Type 1 RNA and DNA in lymph nodes and HIV RNA in genital secretions and in cerebrospinal fluid after suppression of viremia for 2 years. J Infect Dis. 2001 May 1;183(9):1318-27. doi: 10.1086/319864. Epub 2001 Apr 10.

  PMID: 11294662 BACKGROUND

• Gulick RM, Mellors J, Havlir D, Eron J, Gonzalez C, McMahon D, Richman D, Valentine F, Rooney J, Jonas L, Meibohm A, Emini E, Chodakewitz J. Potent and sustained antiretroviral activity of indinavir (IDV), zidovudine (ZDV) and lamivudine (3TC). Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):19 (abstract no ThB931)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; Lamivudine; Stavudine; Zidovudine

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)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Officials

• Havlir D

  STUDY CHAIR

• Richman D

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: December 1, 1997
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (45)