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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00013520

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1125

Expected to finish

2005-06-01

Last updated by the study team

2012-05-21

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Univ. of California Davis Med. Ctr., ACTU — Sacramento, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, California, United States
• Willow Clinic A0507 CRS — San Mateo, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Georgetown University CRS (GU CRS) — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Univ. of Iowa Healthcare, Div. of Infectious Diseases — Iowa City, Iowa, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Alabama Therapeutics CRS — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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