Optimizing Treatment for Treatment-Experienced, HIV-Infected People

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new anti-HIV drug regimen for the suppression of HIV.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: AIDS Clinical Trials Group
• Treatments: Darunavir; Enfuvirtide; Etravirine; Maraviroc; Raltegravir Potassium; Tipranavir

Criteria

Inclusion Criteria:

• HIV-1 infection

• Triple-class drug experience or resistance. More information on this criterion can be found in the protocol.

• Currently on a failing PI-containing regimen that includes 2 other ARVs with no regimen change for 8 weeks prior to study screening

• HIV viral load of 1000 copies/ml or more

• Hepatitis B surface antigen negative within 90 days of study entry

• Able to obtain NRTIs and ritonavir and have required ARVs at time of starting study intervention

• Willing to use acceptable forms of contraception

• Parent or legal guardian willing to provide consent, if applicable

• CD4 count result from a specimen drawn within 120 days prior to study entry

• If any previous HIV-1 viral co-receptor tropism result is available, then most recent specimen date and the tropism result of that specimen AND specimen date and tropism result of any test with either X4 or D/M result, if different from the first specimen, must be available

Inclusion Criteria continued:

• Receipt of successful phenotype/genotype resistance results within 105 days prior to study treatment intervention assignment

• Study team identification of a study regimen and at least 2 NRTIs for participant to take

• Certain abnormal laboratory values. More information on this criterion can be found in the protocol.

Exclusion Criteria:

• Chronic, active hepatitis B virus infection (hepatitis B surface antigen positive or HBV DNA positive)

• Taking certain medications. More information on this criterion can be found in the protocol.

• Known allergy/sensitivity to components of two or more of the study-provided drugs or their formulations. For maraviroc, this includes hypersensitivity or history of allergy to soy lecithin or peanuts.

• Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study

• Pregnancy or breastfeeding

• Use of any immunomodulator (interferons, interleukins, systemic corticosteroids, or cyclosporine), vaccine, or investigational therapy within 30 days prior to study treatment allocation/assignment

• Require certain medications prohibited with study treatment

• Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study treatment allocation are not excluded.