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

NCT00007202 | Completed Phase 2

• 6 other identifiers: AI-03-00510431AIEDRP AI-03-005Substudy AI-03-006Substudy AI-03-007Substudy AI-03-008
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 5

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.

Conditions

HIV Infections

Keywords

Virus Replication; HIV-1; Didanosine; Drug Therapy, Combination; Stavudine; HIV Protease Inhibitors; Sensitivity and Specificity; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; Reverse Transcriptase Polymerase Chain Reaction; Acute Infection

Interventions

Atazanavir DRUG

Stavudine DRUG

Didanosine DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Bristol-Myers Squibb: collaborator

Study Sites (5)

Univ. of Colorado Health Sciences Ctr. AIEDRP

Denver, Colorado, 80262, United States

Location

AIDS Research Consortium of Atlanta, Inc. (ARCA) AIEDRP CRS

Atlanta, Georgia, 30308, United States

Location

Feinberg School of Medicine, HIV/ACTU AIEDRP CRS

Chicago, Illinois, 60611-3015, United States

Location

Rush Univ. Med. Ctr., Dept. of Infectious Disease AIEDRP CRS

Chicago, Illinois, 60612, United States

Location

Centro de Referencia Estadual de AIDS AIEDRP

Salvador, Estado de Bahia, Brazil

Location

MeSH Terms

Conditions

HIV Infections; Hypersensitivity

Interventions

Atazanavir Sulfate; Stavudine; Didanosine

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; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Constance Benson

  STUDY CHAIR

• Robert Schooley

  STUDY CHAIR

• Wheaton Williams

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2000
• First Posted: August 31, 2001
• Study Completion: October 1, 2006
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (4); BR (1)