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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Atazanavir

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Constance Benson

Role: STUDY_CHAIR

Robert Schooley

Role: STUDY_CHAIR

Wheaton Williams

Role: STUDY_CHAIR

Locations

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Univ. of Colorado Health Sciences Ctr. AIEDRP

Denver, Colorado, United States

Site Status

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

Atlanta, Georgia, United States

Site Status

Feinberg School of Medicine, HIV/ACTU AIEDRP CRS

Chicago, Illinois, United States

Site Status

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

Chicago, Illinois, United States

Site Status

Centro de Referencia Estadual de AIDS AIEDRP

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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United States Brazil