Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
First received: December 15, 2000
Last updated: September 20, 2013
Last Verified: September 2013
History of Changes
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.
Drug : Atazanavir
Drug : Stavudine
Drug : Didanosine
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|
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
|Study Completion Date:||October 2006|
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,
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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,
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing 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: NCT00007202
Locations Show More
|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 CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
|Study Chair:||Constance Benson|
|Study Chair:||Robert Schooley|
|Study Chair:||Wheaton Williams|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov Identifier:||NCT00007202 History of Changes|
|Other Study ID Numbers:||AI-03-005|
|Study First Received:||December 15, 2000|
|Last Updated:||September 20, 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
Reverse Transcriptase Polymerase Chain Reaction
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on March 27, 2020
This information is provided by ClinicalTrials.gov.