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Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lopinavir/ritonavir
Efavirenz
Stavudine
Zidovudine
Lamivudine
Tenofovir disoproxil fumarate
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Reverse Transcriptase Inhibitors, HIV Protease Inhibitors, Drug Therapy, Combination, Delayed Action Preparations, Treatment Naive, HIV-1

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Step 1: HIV infected HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry Willing to use acceptable means of contraception d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm Coenrolled in ACTG A5152s Exclusion Criteria for Step 1: On ARV therapy for 7 days or more any time prior to study entry NNRTIs or 3TC at any time prior to study entry Current peripheral neuropathy of Grade 2 or higher Pregnancy or breastfeeding Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded. Human growth hormone within 30 days prior to study entry Initiation of testosterone or anabolic steroids within 30 days prior to study entry Certain other medications within 30 days of study entry Hypersensitivity to components of the study drug formulations Drug or alcohol use or dependence that would interfere with adherence to study requirements Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry Recent infection with drug-resistant HIV

Sites / Locations

  • Alabama Therapeutics CRS
  • USC CRS
  • UCLA CARE Center CRS
  • Stanford CRS
  • UC Davis Medical Center
  • Univ. of California Davis Med. Ctr., ACTU
  • Ucsd, Avrc Crs
  • Ucsf Aids Crs
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • Harbor-UCLA Med. Ctr. CRS
  • University of Colorado Hospital CRS
  • Georgetown University CRS (GU CRS)
  • Univ. of Miami AIDS CRS
  • The Ponce de Leon Ctr. CRS
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Cook County Hosp. CORE Ctr.
  • Methodist Hosp. of Indiana
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Indiana Univ. School of Medicine, Wishard Memorial
  • Univ. of Iowa Healthcare, Div. of Infectious Diseases
  • IHV Baltimore Treatment CRS
  • Johns Hopkins Adult AIDS CRS
  • Massachusetts General Hospital ACTG CRS
  • Bmc Actg Crs
  • Beth Israel Deaconess Med. Ctr., ACTG CRS
  • Brigham and Women's Hosp. ACTG CRS
  • SSTAR, Family Healthcare Ctr.
  • University of Minnesota, ACTU
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Washington U CRS
  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
  • SUNY - Buffalo, Erie County Medical Ctr.
  • Beth Israel Med. Ctr., ACTU
  • NY Univ. HIV/AIDS CRS
  • Cornell CRS
  • Columbia Univ., HIV Prevention and Treatment Medical Ctr.
  • HIV Prevention & Treatment CRS
  • Weill Med. College of Cornell Univ., The Cornell CTU
  • Univ. of Rochester ACTG CRS
  • AIDS Care CRS
  • McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
  • Unc Aids Crs
  • Duke Univ. Med. Ctr. Adult CRS
  • Wake County Health and Human Services CRS
  • Univ. of Cincinnati CRS
  • Case CRS
  • MetroHealth CRS
  • Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases
  • The Ohio State Univ. AIDS CRS
  • Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
  • Hosp. of the Univ. of Pennsylvania CRS
  • Pitt CRS
  • Rhode Island Hosp.
  • The Miriam Hosp. ACTG CRS
  • Vanderbilt Therapeutics CRS
  • University of Washington AIDS CRS
  • Durban Adult HIV CRS

Outcomes

Primary Outcome Measures

Time from study entry to virologic failure
time from study entry to regimen completion

Secondary Outcome Measures

20 % or more loss in peripheral fat
increase in lactic acid levels at least 2-4old above the upper limit of normal (ULN)
20 % or more increase in truncal fat accumulation
fasting cholesterol level equal to or greater than 240 mg/dl
Grade 3 or greater elevation in fasting triglyceride levels
change from baseline in insulin resistance
change from baseline of whole-body bone density and whole-body bone mineral content
time to confirmed virologic failure while on Steps I (initial randomized regimen) or II (within class substitutes for initial regimen toxicity) OR treatment-limiting toxicity on Steps I or II
number of antiretroviral classes with resistance mutations at virologic failure
number of missed medication doses
change from baseline in self-reported symptoms OR occurrence of reporting an increase in symptoms
change from baseline in body image OR occurrence of reporting body image distress
time until treatment-limiting toxicity OR occurrence of Grades 3 or 4 toxicity

Full Information

First Posted
December 30, 2002
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00050895
Brief Title
Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients
Official Title
A Phase III, Randomized, Open-Label Comparison of Lopinavir/Ritonavir Plus Efavirenz Versus Lopinavir/Ritonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.
Detailed Description
Numerous treatment options are available to HIV infected patients who are antiretroviral (ARV) therapy naive, but an optimal regimen has not yet been established. This study will compare a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, a ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen, and a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen for the initial treatment of HIV infection. Patients will be randomly assigned to one of three study arms. In Arm A, patients will receive lopinavir/ritonavir (LPV/r) twice daily and efavirenz (EFV) once daily before bed. Arm B patients will receive LPV/r twice daily, lamivudine (3TC) once daily, plus either stavudine extended release (d4T XR) once daily, zidovudine (ZDV) twice daily, or tenofovir disoproxil fumarate (TDF) once daily. Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed, ZDV twice daily, or TDF once daily before bed. Study visits will occur every 4 weeks until Week 24, then every 8 weeks thereafter for a maximum of 96 weeks. Blood will be drawn at every visit and a urine sample will be collected every 8 weeks. Body measurements will be taken at Weeks 24, 48, 72, and 96. Whole body dual-energy x-ray absorptiometry (DEXA) scans will be done at Weeks 48 and 96. Patients must fast before study visits at Weeks 12, 24, 48, 72, and 96. Women in the study will have gynecological assessments every 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Reverse Transcriptase Inhibitors, HIV Protease Inhibitors, Drug Therapy, Combination, Delayed Action Preparations, Treatment Naive, HIV-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
775 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lopinavir/ritonavir
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate
Primary Outcome Measure Information:
Title
Time from study entry to virologic failure
Title
time from study entry to regimen completion
Secondary Outcome Measure Information:
Title
20 % or more loss in peripheral fat
Title
increase in lactic acid levels at least 2-4old above the upper limit of normal (ULN)
Title
20 % or more increase in truncal fat accumulation
Title
fasting cholesterol level equal to or greater than 240 mg/dl
Title
Grade 3 or greater elevation in fasting triglyceride levels
Title
change from baseline in insulin resistance
Time Frame
at Weeks 24, 48 and 96
Title
change from baseline of whole-body bone density and whole-body bone mineral content
Time Frame
at Weeks 48 and 96
Title
time to confirmed virologic failure while on Steps I (initial randomized regimen) or II (within class substitutes for initial regimen toxicity) OR treatment-limiting toxicity on Steps I or II
Title
number of antiretroviral classes with resistance mutations at virologic failure
Title
number of missed medication doses
Time Frame
4 days prior
Title
change from baseline in self-reported symptoms OR occurrence of reporting an increase in symptoms
Time Frame
at Weeks 4, 48, 72 and 96
Title
change from baseline in body image OR occurrence of reporting body image distress
Time Frame
at Weeks 24, 48, 72 and 96
Title
time until treatment-limiting toxicity OR occurrence of Grades 3 or 4 toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Step 1: HIV infected HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry Willing to use acceptable means of contraception d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm Coenrolled in ACTG A5152s Exclusion Criteria for Step 1: On ARV therapy for 7 days or more any time prior to study entry NNRTIs or 3TC at any time prior to study entry Current peripheral neuropathy of Grade 2 or higher Pregnancy or breastfeeding Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded. Human growth hormone within 30 days prior to study entry Initiation of testosterone or anabolic steroids within 30 days prior to study entry Certain other medications within 30 days of study entry Hypersensitivity to components of the study drug formulations Drug or alcohol use or dependence that would interfere with adherence to study requirements Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry Recent infection with drug-resistant HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Riddler, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard Haubrich, MD
Organizational Affiliation
University of California, San Diego, Division of Infectious Diseases
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Therapeutics CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35924
Country
United States
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-1079
Country
United States
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1793
Country
United States
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305-5107
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
Univ. of California Davis Med. Ctr., ACTU
City
Sacramento
State/Province
California
Country
United States
Facility Name
Ucsd, Avrc Crs
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
ZIP/Postal Code
94305-5107
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
ZIP/Postal Code
94305-5107
Country
United States
Facility Name
Harbor-UCLA Med. Ctr. CRS
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2052
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80262-3706
Country
United States
Facility Name
Georgetown University CRS (GU CRS)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Ponce de Leon Ctr. CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3015
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3806
Country
United States
Facility Name
Cook County Hosp. CORE Ctr.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Methodist Hosp. of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-1261
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5250
Country
United States
Facility Name
Indiana Univ. School of Medicine, Wishard Memorial
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ. of Iowa Healthcare, Div. of Infectious Diseases
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1201
Country
United States
Facility Name
IHV Baltimore Treatment CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Bmc Actg Crs
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Med. Ctr., ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hosp. ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
SSTAR, Family Healthcare Ctr.
City
Fall River
State/Province
Massachusetts
Country
United States
Facility Name
University of Minnesota, ACTU
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0392
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108-2138
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108-2138
Country
United States
Facility Name
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5130
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Beth Israel Med. Ctr., ACTU
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016-6481
Country
United States
Facility Name
Cornell CRS
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032-3784
Country
United States
Facility Name
HIV Prevention & Treatment CRS
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Med. College of Cornell Univ., The Cornell CTU
City
New York
State/Province
New York
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Facility Name
AIDS Care CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
City
Rochester
State/Province
New York
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke Univ. Med. Ctr. Adult CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake County Health and Human Services CRS
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0405
Country
United States
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5083
Country
United States
Facility Name
MetroHealth CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Facility Name
Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-5083
Country
United States
Facility Name
The Ohio State Univ. AIDS CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1282
Country
United States
Facility Name
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Pitt CRS
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Facility Name
Rhode Island Hosp.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
The Miriam Hosp. ACTG CRS
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Vanderbilt Therapeutics CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Durban Adult HIV CRS
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa

12. IPD Sharing Statement

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Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients

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