Clinical trial NCT00002151: A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
Official title: A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
AIDS-Related Complex
Zidovudine
MDL 28574
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Prior antiretroviral agents for up to 6 months per agent.

Patients must have:

* HIV infection.
* Asymptomatic or mildly symptomatic.
* CD4 count 301 - 500 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following condition are excluded:

Unable or unwilling to comply with study procedures.

Concurrent Medication:

Excluded:

* Chemoprophylactic therapy for mycobacterial infection.
* Any nonstudy prescription medications without approval of investigator.

Patients with the following prior conditions are excluded:

* History of grade 3 or 4 toxicity to \<= 600 mg/day AZT.
* History of intolerance to lactose.
* Chronic diarrhea within 6 months prior to study entry.
* Unexplained intermittent or chronic fever, defined as temperature \>= 38.5 C for any 7 days within the 30 days prior to study entry.

Prior Medication:

Excluded:

* Antiretroviral therapy within 2 weeks prior to study entry.
* Prior HIV vaccines.
* Biological response modifiers within 30 days prior to study entry.
* Prior foscarnet.
* Any investigational drug with a washout \< 5 half-lives prior to study entry.
* Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.

Recent history of alcohol and/or drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Clinical Investigations Health Services
state: Alabama
city: Beverly Hills
country: United States
facility: California Clinical Trials Med Group
state: California
city: Los Angeles
country: United States
facility: Southwest Community Based AIDS Treatment Group - COMBAT
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: Washington
country: United States
facility: George Washington Univ / Hershey Med Ctr
state: District of Columbia
city: Coral Gables
country: United States
facility: Community Research Initiative of South Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Independent Investigator
state: Florida
city: Fort Lauderdale
country: United States
facility: North Broward Hosp District
state: Florida
city: Sarasota
country: United States
facility: Clinical Research Ctr
state: Florida
city: Vero Beach
country: United States
facility: Independent Investigator
state: Florida
city: Chicago
country: United States
facility: Ctr for Special Immunology
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: New Orleans
country: United States
facility: New Orleans Institute of Clinical Investigation
state: Louisiana
city: Detroit
country: United States
facility: Univ Health Ctr
state: Michigan
city: Kansas City
country: United States
facility: Antibiotic Research Associates
state: Missouri
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: Rochester
country: United States
facility: Community Health Network
state: New York
city: Stony Brook
country: United States
facility: SUNY / Health Sciences Ctr at Stony Brook
state: New York
city: Toledo
country: United States
facility: Infectious Disease Associates
state: Ohio
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Sayre
country: United States
facility: Guthrie Clinic
state: Pennsylvania
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
Study officials:
References: