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Home > "W" Clinical Trials Conditions > When to Start Anti-HIV Drugs in Patients with Opportunistic Infections  When to Start Anti-HIV Drugs in Patients with Opportunistic Infections
When to Start Anti-HIV Drugs in Patients with Opportunistic Infections
For Condition: HIV Infections,AIDS-Related Opportunistic Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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 and/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. Patients in this study will be randomized 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 at least 4 weeks and no more than 32 weeks after beginning therapy for the acute OI. All patients will be offered the study-provided antiretroviral drugs: lopinavir/ritonavir in combination with stavudine. A third or fourth antiretroviral drug is at the discretion of the study official, although lamivudine is strongly recommended. 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. Study visits will include a physical exam, blood tests, and patient questionnaires. Patients in Arm A are eligible for a substudy to evaluate the pharmacokinetics of the study drugs in patients with Pneumocystis carinii pneumonia, bacterial pneumonia, or other respiratory infections.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV-1 infection - Confirmed or probable acute infections, including Pneumocystis carinii pneumonia (PCP), bacterial pneumonia with CD4 cell count < 200 cells/mm3, cryptococcal meningitis, disseminated histoplasmosis, disseminated Mycobacterium avium complex, cytomegalovirus retinitis, cytomegalovirus encephalitis, and toxoplasmic encephalitis - Treatment for current OI or bacterial pneumonia - Ability to take oral medications - Ability and willingness of participant or legal guardian to give written informed consent - Acceptable methods of contraception Exclusion Criteria - Prior antiretroviral therapy as defined by either ART within the 6 months prior to study entry or more than a total of 6 months of ART prior to study entry - Pregnant or breastfeeding - 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 HCV or Kaposi’s sarcoma) - Investigational antiretroviral agents - Systemic investigational agents (except antiretroviral drugs) within 30 days prior to study entry will be allowed at the study official’s discretion - Anticipated use of certain medications - Renal failure requiring dialysis - Assisted ventilation required at the time of study entry - Discharge from an intensive care area within 96 hours prior to enrollment - Drug or alcohol use that, in the opinion of the study official, would interfere with the study - Pulmonary histoplasmosis without dissemination - Treatment for current OI or bacterial pneumonia for more than 14 days prior to study entry - Known resistance to ART - Recurrence of certain OIs (other than PCP and bacterial pneumonia)
Total Enrollment: 282
Location and Contact Information:
Overall Study Official:
AndrewZolopa, Study Chair, Stanford University
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Univ of Rochester Med Ctr *Recruiting*
Rochester, New York, 14642-0001
United States
Recruiting Carol Greisberger 585-275-2740
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Suzanne Aycock 919-684-8216
Harbor General/UCLA *Recruiting*
Torrance, California, 90502-2052
United States
Recruiting Mario Guerrero 310-222-3848
Harvard (Massachusetts General Hospital) *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Teri Flynn 617-724-0072
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 46202-5250
United States
Recruiting Beth Zwickl 317-274-8456
Community Health Network, Inc. *Recruiting*
Rochester, New York, 14642-0001
United States
Recruiting Carol Greisberger 585-275-2740
Methodist Hospital of Indiana *Recruiting*
Indianapolis, Indiana, 46202-1261
United States
Recruiting Sarah Ryan 317-929-2917
UC Davis Med Ctr *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
Univ of Colorado Health Sciences Ctr, Denver *Recruiting*
Denver, Colorado, 80262-3706
United States
Recruiting M. Ray 303-372-5535
Brigham and Womens Hospital *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Carolyn Koziol 617-732-5635
Univ of North Carolina *Recruiting*
Chapel Hill, North Carolina, 27514
United States
Recruiting Cheryl Marcus 919-843-8761
Columbia Univ *Recruiting*
New York City, New York, 10021
United States
Recruiting Mykyelle Crawford 212-305-2665
Univ of California, Davis Med Ctr *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
Univ of Miami *Recruiting*
Miami, Florida, 33136-1013
United States
Recruiting Leslie Thompson 305-243-3838
University of Witwatersrand *Recruiting*
PARKTOWN, Johannesburg,
South Africa
Recruiting Pauline Vunandlala 01-27-11-717-2810
San Mateo County AIDS Program *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Washington Univ (St. Louis) *Recruiting*
St. Louis, Missouri, 63108-2138
United States
Recruiting Michael Klebert 314-454-0058
NYU/Bellevue *Recruiting*
New York City, New York, 10016-6481
United States
Recruiting Maura Laverty 212-263-6565
Willow Clinic *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbbie Slamowitz 650-723-2804
Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Todd Lusch 614-293-8112
Emory University *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Ericka Patrick 404-16-6313
Santa Clara Valley Medi Ctr *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Univ of Texas, Galveston *Recruiting*
Galveston, Texas, 77555-0435
United States
Recruiting Carrier Derkowksi 409-747-0241
San Francisco General Hosp *Recruiting*
San Francisco, California, 94110
United States
Recruiting Michele Downing 415-514-0550
Stanford Univ *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Beth Israel Medical Center *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Beth Israel Deaconess - West Campus *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Helen Fitch 617-632-0785
St. Louis Connect Care *No longer recruiting*
St. Louis, Missouri, 63108-2138
United States
No longer recruiting
Additional Information:
Study ID Numbers: ACTG A5164;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055120
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3. Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines
4. A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine
5. A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers
Related Studies:
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When to Start Anti-HIV Drugs in Patients with Opportunistic Infections
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