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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Didanosine; Stavudine

Criteria

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.