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Home > "A" Clinical Trials Conditions > A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients  A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole) for the prevention of serious fungal disease. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis.
Details: Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis. All patients receive AZT. In addition, they are placed in one of three groups to receive either SMX/TMP, dapsone, or PEN. Stratification criteria are: Received first AZT equal to or less than 6 weeks prior to study entry. Received first AZT more than 6 weeks prior to study entry. Potential to participate in ACTG 981. ACTG center in which the patient is enrolled.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antifolate medication required to treat an intercurrent infection. - Treatment of intercurrent infections or malignancies. - Fluconazole. - Itraconazole. - Standard or investigational therapy for pneumocystosis (PCP) or toxoplasmosis. - Only the forms of primary prophylaxis for PCP or toxoplasmosis assigned to the participant under the protocol. Patients who develop intolerance to all forms of prophylaxis assigned in this protocol or who develop PCP or toxoplasmosis may receive alternate or investigation forms of prophylaxis with or without zidovudine but must continue to be followed under this protocol. - Discouraged but allowed: AL-721. - Chronic acyclovir. - Ketoconazole. - Amphotericin B. - Corticosteroids at greater than physiologic replacement doses are strongly discouraged. - They should be used as briefly as possible and only for definite specific indications. Patient must conform to the following: - Receiving or candidates for zidovudine therapy at least 500 mg/day under current labeled indications with no history of pneumocystosis (PCP) or toxoplasmosis. - Evidence of HIV infection documented by HIV antibody tests. - T4 cell count less than 200 cells/mm3 at any time prior to study entry. - Willing to sign informed consent. - Willing to be followed by a participating ACTG center for duration of the study. - Allowed: Concurrent enrollment in long-term follow-up studies in previously blinded trials of AZT (ACTG 016 and 019). Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: - History of documented or presumed pneumocystosis (PCP) or toxoplasmosis. - Active bacterial or mycobacterial infection. - History of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine. - History of intolerance causing dose interruption while receiving zidovudine at equal to or less than 600 mg/day or causing dose reduction to less than 500 mg/day within 4 weeks prior to entry. - Advanced Kaposi's sarcoma or other malignancy not specifically allowed that has been rapidly progressive during the month prior to enrollment or which may be expected to require chemotherapy within 90 days of study entry. Concurrent Medication: Excluded: - Active primary treatment for an infection or malignancy. - Other form of antifolate medication not specifically allowed. - Other antiretroviral or biologic response modifier. - Ganciclovir, if it causes intolerance to AZT equal to or more than 500 mg/day. - Foscarnet. Patients with the following are excluded: - Symptoms and conditions defined in Exclusion Coexisting Conditions. - Glucose 6-phosphate dehydrogenase deficiency (GPD). - History of pneumocystosis (PCP) or toxoplasmosis. - History of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine. - History of intolerance causing dose interruption while receiving zidovudine at equal to or less than 500 mg/day with 4 weeks pior to study entry. Prior Medication: Excluded within 4 weeks of study entry: - Any other form of pneumocystosis (PCP) chemoprophylaxis. - Active substance abuse, including alcohol.
Total Enrollment: 600
Location and Contact Information:
Overall Study Official:
SBozzette, Study Chair,
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Stanford Private Practice
Redwood City, California,
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Washington
Seattle, Washington, 98105
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
UCSD Treatment Ctr
San Diego, California, 92103
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Northern California Pediatric AIDS Treatment Ctr / UCSF
San Francisco, California, 94143
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Additional Information:
Study ID Numbers: ACTG 081;
Study Start Date:
Record last reviewed: October 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000991
Other Pneumonia, Pneumocystis Carinii Studies:
1. A Study of Trimetrexate in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Not Previously Treated for PCP
2. Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children.
3. A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS
4. A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
5. Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis carinii Pneumonia Prophylaxis
Related Studies:
Other Pneumonia, Pneumocystis carinii Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
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