When to Start Anti-HIV Drugs in Patients With Opportunistic Infections
HIV Infections, AIDS-Related Opportunistic Infections
About this trial
This is an interventional diagnostic trial for HIV Infections focused on measuring Anti-HIV Agents, Disease Progression, Drug Administration Schedule, Viral Load, HIV-1, Treatment Outcome, Survival Analysis, Treatment Naive
Eligibility Criteria
Note: Participants who enrolled in this study prior to Version 3.0 will be offered and allowed to switch to FTC/TDF if they wish. However, participants under the age of 18 cannot receive FTC/TDF through this study. Inclusion Criteria for Step 1: HIV-1 infected Currently being treated for OI (including Pneumocystis carinii pneumonia [PCP]; cryptococcal meningitis; disseminated histoplasmosis; disseminated Mycobacterium avium complex [MAC]; cytomegalovirus [CMV] retinitis; CMV encephalitis; toxoplasmic encephalitis; other atypical non-tuberculous, non-MAC mycobacterial infections; or other serious, invasive BIs). Participants who have tuberculosis (TB) alone are ineligible for this study. Participants with bacterial pneumonia or serious BI must have a CD4 count less than 200 cells/mm3 within 30 days prior to study entry. Participants with other serious OIs, including other AIDS-defining and -related OIs for which appropriate therapy other than ART exists are eligible, pending investigator approval. Participants' current OI treatment must have been started within 14 days prior to study entry, but may have been discontinued prior to study entry. Able to take oral medications Parent or guardian willing to provide informed consent, if applicable Willing to use acceptable methods of contraception Exclusion Criteria for Step 1: Any ART within 8 weeks prior to study entry 31 or more days of any ARV within 6 months prior to entry History of more than one virologic, immunologic, or clinical treatment failure while on a HAART regimen, or a history of more than one regimen change for unknown reasons Systemic cancer chemotherapy within 30 days prior to study entry Immunomodulators within 30 days prior to study entry, including growth factors, immune globulin, interleukins, and interferons (unless for hepatitis C virus or Kaposi's sarcoma) Investigational ARV agents at study entry Systemic investigational agents (except ARV drugs) within 30 days prior to study entry will be allowed at the study official's discretion Anticipated use of certain medications Kidney failure requiring dialysis Current drug or alcohol use that, in the opinion of the study official, would interfere with the study Treatment for current, first-treated, and diagnosed OI or BI for more than 14 days prior to study entry Known resistance to ART that prohibits administration of an effective ART regimen Current OI has recurred within 90 days prior to study entry. Recurrent BIs are not excluded. Pregnant or breastfeeding
Sites / Locations
- University of California, Davis Medical Center
- University of California, San Diego Antiviral Rese
- San Francisco General Hospital
- San Mateo County AIDS Program
- Santa Clara Valley Medical Center
- Stanford Univ
- Willow Clinic
- Harbor General/UCLA
- University of Colorado Health Sciences Center, Denver
- Univ of Miami
- Emory University
- Northwestern University
- Cook County Hospital Core Center
- Methodist Hospital of Indiana
- Indiana University Hosp
- Wishard Hospital
- University of Maryland, Institute of Human Virology
- Johns Hopkins University
- Harvard (Massachusetts General Hospital)
- Beth Israel Deaconess - West Campus
- Brigham and Womens Hospital
- Hennepin County Medical Clinic
- St. Louis Connect Care
- Washington University (St. Louis)
- Beth Israel Medical Center
- NYU/Bellevue
- Columbia University
- Community Health Network, Inc.
- University of Rochester Medical Center
- University of North Carolina
- Duke University Medical Center
- University of Cincinnati
- Case Western Reserve University
- MetroHealth Medical Center
- Ohio State University
- Presbyterian Medical Center - University of PA
- University of Pennsylvania, Philadelphia
- Rhode Island Hospital
- The Miriam Hospital
- Comprehensive Care Clinic
- University of Texas, Southwestern Medical Center
- Univ of Texas, Galveston
- University of Washington (Seattle)
- University of Puerto Rico
- University of Witwatersrand