When to Start Anti-HIV Drugs in Patients With Opportunistic Infections
- Conditions
- AIDS-Related Opportunistic InfectionsHIV Infections
- Registration Number
- NCT00055120
- Brief Summary
The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
- Detailed Description
Despite the advent of highly active antiretroviral therapy (HAART), many HIV infected patients without access to antiretroviral therapy (ART) present with acute OIs. Such presentations pose a management problem, as there are currently no data available as to whether initiating HAART during the acute presentation is of benefit. Reports of an immune reconstitution inflammatory syndrome (IRIS) marked by increasing hypoxia or new pulmonary infiltrates have been associated with the initiation of ART in patients with AIDS. There is also concern as to drug interactions between ART and antimicrobials used to treat the presenting OI. This study will evaluate the possible benefits and costs of initiating ART in HIV infected patients who present with an AIDS-defining OI.
There are 2 steps in this study. In Step 1, patients will be randomly assigned to one of two study arms. Arm A will receive ART within 2 weeks of starting therapy for the acute OI. Arm B will have ART deferred until Step 2, at least 4 weeks and no more than 32 weeks after beginning therapy for the acute OI. Only Arm B participants will enter Step 2, which will likely begin between Weeks 6 and 12. The study will make the following drugs available for construction of an antiretroviral (ARV) regimen: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/RTV), and stavudine (d4T). Use of other ARV drugs is at the discretion of the study official. Drug regimen additions and substitutions will be made on a case-by-case basis.
Patients will be followed for 48 weeks and will have 10 study visits. All study visits will include a physical exam, medication history, and blood collection. Patients will be asked to complete questionnaires assessing health status and adherence at selected visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
- Secondary Outcome Measures
Name Time Method HIV-1 plasma viral load at all timepoints up to and including Week 48 CD4 counts at all timepoints up to and including Week 48 changes in ARV regimen for lack of efficacy efficacy of treatment and clinical outcomes for specific OI/BI, including duration of and complications of treatment, incidence and duration of hospitalization, rate of relapse/recurrence, and incidence of IRIS and impact on outcomes in the two arms safety and tolerability, measured by Grade 3 and 4 signs and symptoms and laboratory toxicities, ART and OI/BI treatment changes and dose modifications due to toxicities, and IRIS HIV-1 drug resistance over time (genotype) health care resource use, including total inpatient days and emergency room visits compared in the two groups quality of life (QOL) and functional status outcomes, including overall self-reported QOL and functional status compared in the two groups at Week 48 adherence, including self-reported adherence to all ARVs over the study period, examined for relationship with primary study outcomes, including death, progression, and viral suppression
Trial Locations
- Locations (45)
Brigham and Womens Hospital
🇺🇸Boston, Massachusetts, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Santa Clara Valley Medical Center
🇺🇸Stanford, California, United States
San Mateo County AIDS Program
🇺🇸Stanford, California, United States
University of California, San Diego Antiviral Rese
🇺🇸San Diego, California, United States
Willow Clinic
🇺🇸Stanford, California, United States
University of Colorado Health Sciences Center, Denver
🇺🇸Denver, Colorado, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Univ of Miami
🇺🇸Miami, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Maryland, Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
Cook County Hospital Core Center
🇺🇸Chicago, Illinois, United States
Wishard Hospital
🇺🇸Indianapolis, Indiana, United States
Methodist Hospital of Indiana
🇺🇸Indianapolis, Indiana, United States
Indiana University Hosp
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Harvard (Massachusetts General Hospital)
🇺🇸Boston, Massachusetts, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Hennepin County Medical Clinic
🇺🇸Minneapolis, Minnesota, United States
St. Louis Connect Care
🇺🇸St. Louis, Missouri, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Columbia University
🇺🇸New York, New York, United States
Washington University (St. Louis)
🇺🇸St. Louis, Missouri, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
NYU/Bellevue
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Presbyterian Medical Center - University of PA
🇺🇸Philadelphia, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pennsylvania, Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Comprehensive Care Clinic
🇺🇸Nashville, Tennessee, United States
University of Washington (Seattle)
🇺🇸Seattle, Washington, United States
Univ of Texas, Galveston
🇺🇸Galveston, Texas, United States
University of Witwatersrand
🇿🇦Parktown, Johannesburg, South Africa
Stanford Univ
🇺🇸Stanford, California, United States
Community Health Network, Inc.
🇺🇸Rochester, New York, United States
Harbor General/UCLA
🇺🇸Torrance, California, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
University of Texas, Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States