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Home > "A" Clinical Trials Conditions > A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection



A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration. The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
Details: The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity. Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks. PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV-1 seropositivity. - CD4 count >= 550 cells/mm3. - Asymptomatic disease. - No prior antiretroviral therapy. - Consent of parent or guardian if less than 18 years old. PER AMENDMENT 6/18/96: - Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Medical condition that precludes study compliance. Concurrent Medication: Excluded: - Antiretrovirals other than study drugs. - Biologic response modifiers including erythropoietin and G-CSF. - Systemic corticosteroids. - Systemic cytotoxic chemotherapy. - Intravenous pentamidine. Concurrent Treatment: Excluded: - Systemic radiation therapy. Patients with the following prior conditions are excluded: - History of grade 2 or worse peripheral neuropathy. - History of pancreatitis or factors predisposing to pancreatitis. Prior Medication: Excluded: - Prior antiretrovirals. - Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry. Chronic alcoholism.
Total Enrollment: 85

Location and Contact Information:

Overall Study Official:
CollierAC,  Study Chair, 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Louis A Weiss Memorial Hosp
Chicago,  Illinois,  60640
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Univ of Washington
Seattle,  Washington,  981224304
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Jack Weiler Hosp / Bronx Municipal Hosp
Bronx,  New York,  10465
United States
 

San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Illinois Masonic Med Ctr
Chicago,  Illinois,  606575147
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 

Brigham and Women's Hosp
Boston,  Massachusetts,  02115
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 


Additional Information:
Study ID Numbers:
  ACTG 276; 
Study Start Date: 
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000823

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4. A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea

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