Clinical trial NCT00000823: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Didanosine
Drug Therapy, Combination
Zidovudine
Drug Administration Schedule
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Bristol-Myers Squibb
name: Glaxo Wellcome
First posted: 2001-08-31
Enrollment: 85
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Cook County Hosp
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Chicago
country: United States
facility: Louis A Weiss Memorial Hosp
state: Illinois
city: Chicago
country: United States
facility: Illinois Masonic Med Ctr
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hosp of Indiana / Life Care Clinic
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Harvard (Massachusetts Gen Hosp)
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hosp
state: Massachusetts
city: Bronx
country: United States
facility: Jack Weiler Hosp / Bronx Municipal Hosp
state: New York
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Univ of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
Study officials:
name: Collier AC
role: STUDY_CHAIR
name: Johnson V
role: STUDY_CHAIR
References: