Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness, safety, and tolerability of 3 anti-HIV combination treatments that do not use protease inhibitors (PIs).

The current rule for starting treatment of HIV infection is to combine members from different classes of anti-HIV drugs, such as 2 nucleoside reverse transcriptase inhibitors (NRTIs) and either a PI or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, these combinations can be complicated and difficult to take, can cause a number of side effects, and may become ineffective. Combinations that are simpler, better tolerated, and more effective are needed. Because PIs can cause long-term side effects and because HIV can become resistant to many of them at the same time, anti-HIV combination treatments that do not use PIs are being tested.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Atazanavir Sulfate; Didanosine; Dideoxynucleosides; Efavirenz; HIV Protease Inhibitors; Lamivudine; Lamivudine, zidovudine drug combination; Nevirapine; Protease Inhibitors; Stavudine; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have a viral load of at least 400 copies/ml within 90 days prior to study entry.

• Are at least 16 years old.

• Weigh at least 40 kg.

• Have a negative pregnancy test within 48 hours before starting study drugs, if female and able to have children.

• Agree to use 2 effective methods of birth control while taking, and for 3 months after stopping, the study medications.

• Provide written consent of a parent or guardian, if under 18 years of age.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have taken anti-HIV drugs in the past.

• Are allergic to any of the study drugs or ingredients.

• Are pregnant or breast-feeding.

• Have taken any of the following drugs within 14 days prior to study entry: amiodarone, astemizole, bepridil, cisapride, ergot or ergot derivatives, systemic itraconazole, systemic ketoconazole, midazolam, propoxyphene, quinidine, rifampin, terfenadine, thalidomide, triazolam, or St. John's wort.

• Have taken drugs that influence the immune system, HIV or other vaccines, or investigational drugs within 30 days prior to study entry. Prednisone at a dose of 10 mg or less daily is allowed.

• Have taken drugs or been hospitalized for serious infections or medical illnesses within 14 days prior to study entry.

• Have growths or tumors that require drug therapy.

• Have Pneumocystis carinii pneumonia that is not clinically stable and whose treatment is not completed at least 7 days prior to study entry.

• Have infections or medical illnesses that are not under control or that have not received complete treatment before study entry.

• Have any condition that, in the opinion of the investigator, would prevent them from properly participating in the study.

• Abuse drugs or alcohol.

• This study has been updated to exclude patients who are receiving systemic itraconazole and rifabutin.