Status:
COMPLETED
Comparative Study of Three NNRTI-Sparing HAART Regimens
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly...
Detailed Description
Of the five anti-HIV drug classes, four were recommended as first-line regimens for patients who have never received anti-HIV treatment before (treatment naive): nucleoside reverse transcriptase inhib...
Eligibility Criteria
Inclusion
- HIV-1 infected
- No evidence of any exclusionary mutations defined as any major NRTI or PI resistance-associated mutation on any genotype or evidence of significant NRTI or PI resistance on any phenotype performed at any time prior to study entry. NNRTI-associated resistance mutations are not excluded. More information on this criterion can be found in the study protocol.
- No prior anti-HIV therapy. More information on this criterion can be found in the study protocol.
- Viral load is 1000 copies/mL or higher, as measured within 90 days prior to study entry
- Certain laboratory values obtained within 60 days prior to study entry
- Ability to obtain RTV by prescription
- Completed cardiovascular risk assessment. More information on this criterion can be found in the study protocol.
- Must agree to use acceptable forms of contraception while receiving study drugs and for 6 weeks after stopping the medications. More information on this criterion is available in the protocol.
- Negative pregnancy test within 72 hours before initiating antiretroviral medication
- Participating in research at any AIDS Clinical Trial Group (ACTG) clinical research site or select International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) group sites
- Ability and willingness of subject or legal guardian/representative to give written informed consent
Exclusion
- Use of immunomodulators, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Those using stable physiologic glucocorticoid doses, a short course of pharmacologic glucocorticoid, corticosteroids for acute therapy treating an opportunistic infection, inhaled or topical corticosteroids, or granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) will not be excluded.
- Known allergy or sensitivity to study drugs or their ingredients. A history of sulfa allergy is not excluded.
- Any condition that, in the opinion of the investigator, would compromise the participant's ability to participate in the study
- Serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 7 days prior to study entry
- Requirement for any current medications that are prohibited with any study drugs
- Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness
- Any prior use of entecavir for treatment of hepatitis B for greater than 8 weeks while the participant was known to be HIV infected
- Presence of decompensated cirrhosis
- Pregnant or breastfeeding
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
1814 Patients enrolled
Trial Details
Trial ID
NCT00811954
Start Date
May 1 2009
End Date
June 1 2013
Last Update
September 5 2014
Active Locations (57)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294-2050
2
Miller Children's Hospital
Long Beach, California, United States, 90806
3
USC CRS
Los Angeles, California, United States, 90033
4
UCLA CARE Center CRS
Los Angeles, California, United States, 90035