A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
Official Title ^ICMJE	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
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Atevirdine mesylate Drug: Zidovudine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002322
Responsible Party
Study ID Numbers ^ICMJE	210A, M/3330/0018
Study Sponsor ^ICMJE	Pharmacia and Upjohn
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 1996
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP