A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation

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

Summary

Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor. Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take them as prescribed and get the best results. This study will see if people are more successful in taking anti-HIV drugs once a day or twice a day. It also will determine if having a health care professional oversee each weekday dose helps people control their HIV infection. The study will compare taking a three-drug combination twice a day versus taking a three-drug combination just once a day. The study will also compare patients taking the drugs on their own to patients taking the drugs in the presence of a clinical worker. Viral load (amount of HIV in the blood) and drug side effects will be measured.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Emtricitabine; Lopinavir; Ritonavir; Stavudine; Tenofovir

Criteria

Inclusion Criteria

• HIV infection

• Age 13 years or older and have written consent of guardian if under 18

• Weigh at least 88 pounds

• Viral load of 2000 copies/ml or more within 90 days before study entry

• Have not taken anti-HIV drugs for more than 7 days

• Agree to use acceptable methods of contraception during the study and for 1 month after stopping the study drugs

Exclusion Criteria

• Pregnant or breastfeeding

• In jail

• Sensitive or allergic to any part of the study drugs

• Treated with acute systemic therapy for a serious infection or other serious medical illness within 7 days prior to study entry, unless the participant has completed 7 days of therapy and is clinically stable

• Recent serious illness, including pancreatitis or peripheral neuropathy

• Alcohol or illicit drug abuse

• Taken any of the following within 14 days before study entry: investigational drugs, anti-HIV vaccines, drugs that may cause pancreatitis or peripheral neuropathy, or drugs that are associated with CYP3A

• Treated for cancer (not including minimal Kaposi's sarcoma) within 30 days before study entry

• History of mental illness that might interfere with the study