Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00007202
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : September 23, 2013
Bristol-Myers Squibb
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

The purpose of this study is to determine the safety and effectiveness of stavudine (d4T), didanosine (ddI), and BMS-232632 when given early in the course of HIV infection.

Acute HIV infection may develop in patients that are exposed to the HIV virus. Following infection, the viral load (level of HIV in the blood) rises rapidly over the next few days to weeks. It is not known which is the best treatment in patients with very early HIV infection. Researchers believe these patients may respond well to strong early treatment. A combination consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632, will be tested.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Atazanavir Drug: Stavudine Drug: Didanosine Phase 2

Detailed Description:

Acute primary HIV-1 infection (PHI) follows exposure to the HIV-1 virus and results in a rapid rise in plasma viremia within days to 1 to 3 weeks. Individuals with acute PHI or early HIV-1 infection represent a potentially unique patient population in which to evaluate potent antiretroviral therapies because of the degree of viral heterogeneity and the fact that immunologic disruption is likely to be lower than in later stages of HIV-1 disease. The optimal treatment for acute PHI is unknown. This study evaluates a regimen consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632.

Patients are enrolled into Group I or Group II and may participate in substudies. Patients in Group I receive ddI-EC, d4T, and BMS-232632 daily for 52 weeks. Clinical, virologic, and immunologic evaluations are performed on Days 2, 7, 14, 21, and 28, then every 4 weeks through Week 24, and then every 8 weeks thereafter through Week 48. Based on laboratory results from the Week 48 visit, a decision is made by Week 52 whether or not to continue study medications for an additional 52 weeks. Evaluation schedules for those patients enrolled in substudies may be different. Group II patients elect not to receive antiretroviral treatment and are followed as a natural history disease group to be compared with patients in Group I. They are followed according to the same schedule of evaluations as those enrolled in Group I, unless otherwise specified as part of their participation in substudies. All patients are followed in this study at 8-week intervals for a total duration of 104 weeks (2 years). HIV will be measured in plasma and tissues to determine reduction in replication for a duration of at least 48 weeks.

The 3 substudies in which patients may participate are AI-03-006, Lymphoid Tissue Substudy; AI-03-007, Immunology Substudy of cytolytic and co-stimulatory markers, T-cell repertoire, and cytokine and chemokine elaboration; and AI-03-008, Viral Dynamics and Diversity Substudy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Primary Purpose: Treatment
Official Title: A Pilot Open-Label Phase II Clinical Trial to Evaluate the Safety and Efficacy of a Compact Three Drug Antiretroviral Treatment Regimen for Subjects With Acute HIV-1 Infection or Recent HIV-1 Seroconversion
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients may be eligible for this study if they:

  • Have early HIV infection or show recent seroconversion (going from HIV-negative to HIV-positive).
  • Are at least 18 years old.
  • Agree to 2 barrier methods of birth control, if heterosexually active men or women, during the study and for 3 months after.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have received prior antiretroviral therapy.
  • Have received interferons, interleukins, colony-stimulating factors, radiation, cytotoxic chemotherapy, or HIV vaccines within 30 days prior to study entry.
  • Have had any experimental therapy within 30 days prior to study entry.
  • Are pregnant or breast-feeding.
  • Patients will not be eligible for Group I if they:
  • Have had pancreatitis (inflammation of the pancreas).
  • Have received alpha tocopherol (vitamin E), amiodarone, astemizole, carbamazepine, cisapride, ergotamine/diergotamine, estrogens, fluvastatin, glucocorticoids, itraconazole, ketoconazole, midazolam, phenobarbital, phenytoin, quinidine, rifampin, rifabutin, sildenafil, statin drugs (simvastatin, pravastatin, atorvastatin) used for reduction of triglyceride or cholesterol levels, terfenadine, triazolam, or warfarin within 14 days of study entry.
  • Have received chloramphenicol, cisplatin, clioquinol, dapsone, diphenylhydantoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, isoniazid, metronidazole, pyridoxine, sodium cyanate, thalidomide, vincristine, or zalcitabine within 30 days of study entry. In certain cases, patients taking these drugs may still be eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00007202

United States, Colorado
Univ. of Colorado Health Sciences Ctr. AIEDRP
Denver, Colorado, United States, 80262
United States, Georgia
AIDS Research Consortium of Atlanta, Inc. (ARCA) AIEDRP CRS
Atlanta, Georgia, United States, 30308
United States, Illinois
Feinberg School of Medicine, HIV/ACTU AIEDRP CRS
Chicago, Illinois, United States, 60611-3015
Rush Univ. Med. Ctr., Dept. of Infectious Disease AIEDRP CRS
Chicago, Illinois, United States, 60612
Centro de Referencia Estadual de AIDS AIEDRP
Salvador, Bahia, Brazil
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb
Study Chair: Constance Benson
Study Chair: Robert Schooley
Study Chair: Wheaton Williams

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00007202     History of Changes
Other Study ID Numbers: AI-03-005
10431 ( Registry Identifier: DAIDS ES )
AIEDRP AI-03-005
Substudy AI-03-006
Substudy AI-03-007
Substudy AI-03-008
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Virus Replication
Drug Therapy, Combination
HIV Protease Inhibitors
Sensitivity and Specificity
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Reverse Transcriptase Polymerase Chain Reaction
Acute Infection

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors