Clinical trial NCT00002322: A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
Official title: Randomized, Double-Blind, Placebo-Controlled Comparative Dose-Response Study of Two Doses of Atevirdine Mesylate (U-87201E) in Combination With Fixed Doses of Zidovudine (AZT) in HIV+ Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT).

Detailed description: Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Primary or secondary prophylaxis for opportunistic infections.

Patients must have:

* HIV infection.
* Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED:
* Cryptococcosis
* Pneumocystis carinii pneumonia
* Herpes zoster
* Histoplasmosis
* CMV
* Hepatic or renal disease
* Lymphoma.
* CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry.
* Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry.
* Consent of parent, guardian, or person with power of attorney if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Intolerance to AZT.
* Current diagnosis of malignancy for which systemic therapy will be required during the study.

Concurrent Medication:

Excluded:

* Any other investigational drugs.

Prior Medication:

Excluded:

* Cytotoxic chemotherapy within 1 month prior to study entry.
* Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors.
* Antiretroviral agents other than AZT within 3 months prior to study entry.

Required:

* AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County / Health Research Assoc / Drew Med Ctr
state: California
city: Orange
country: United States
facility: UCI Med Ctr
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Boston City Hosp / FGH-1
state: Massachusetts
city: East Orange
country: United States
facility: East Orange Veterans Administration Med Ctr
state: New Jersey
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: Pawtucket
country: United States
facility: Mem Hosp of Rhode Island
state: Rhode Island
city: Houston
country: United States
facility: Park Plaza Hosp
state: Texas
city: San Antonio
country: United States
facility: Univ TX San Antonio Health Science Ctr
state: Texas
city: Milwaukee
country: United States
facility: Wisconsin Community - Based Research Consortium
state: Wisconsin
Study officials:
References: