Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Combination antiretroviral therapy including two nucleoside reverse transcriptase inhibitors (NRTIs) and a single HIV-1 protease inhibitor (PI) results in significant and sustained decreases in plasma HIV-1 RNA with a resultant marked diminution in the selection of drug-resistant variants in those able to adhere to and tolerate these regimens. However, two lines of evidence suggest that additional and perhaps more aggressive approaches may be necessary in some HIV-infected individuals: 1) the failure of some potent three-drug regimens to sustain viral replication to levels below the limits ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patient may be eligible if they:
• • Are in the early stages of HIV infection.
• • Are at least 13 years old (consent of parent or guardian required if under 18).
• • Agree to use 2 barrier methods of birth control (such as condoms) during the study and for 3 months after.
• • Exclusion Criteria
• Patients will not be eligible if they:
• • Have a liver or kidney problem (Group I only).
• • Have a history of pancreatitis (Group I only).
• • Have ever taken anti-HIV drugs before.
• • Plan to take anti-HIV drugs other than the study drugs during the study. (Study drugs may be substituted if the investigator finds it necessary.)
• • Have had radiation treatment within 30 days prior to study entry.
• • Have received chemotherapy or any experimental therapy within 30 days of study entry or plan to receive such therapies during the study.
• • Have taken interferons, interleukins, colony-stimulating factors, and HIV vaccines within 30 days prior to study entry.
• • Have taken certain other drugs.
• • Are pregnant or breast-feeding.