Optimizing Treatment for Treatment-Experienced, HIV-Infected People

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00537394

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

517

Starts

2008-01-01

Expected to finish

2013-04-01

Last updated by the study team

2021-11-04

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach, California, United States
• University of Southern California CRS — Los Angeles, California, United States
• Usc La Nichd Crs — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• Stanford AIDS Clinical Trials Unit CRS — Palo Alto, California, United States
• UCSD Antiviral Research Center CRS — San Diego, California, United States
• Ucsf Hiv/Aids Crs — San Francisco, California, United States
• Univ. of California San Francisco NICHD CRS — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Denver Public Health CRS — Denver, Colorado, United States
• Georgetown University CRS (GU CRS) — Washington D.C., District of Columbia, United States
• Children's National Med. Ctr. ATN CRS — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Pediatric Perinatal HIV Clinical Trials Unit CRS — Miami, Florida, United States
• The Ponce de Leon Center CRS — Atlanta, Georgia, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Rush University CRS — Chicago, Illinois, United States
• Tulane Univ. New Orleans NICHD CRS — New Orleans, Louisiana, United States
• IHV Baltimore Treatment CRS — Baltimore, Maryland, United States
• Johns Hopkins University CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital CRS (MGH CRS) — Boston, Massachusetts, United States
• Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Alabama Therapeutics CRS — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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