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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Pharmacia and Upjohn ,
Synopsis: 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).
Details: 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:
Study Type:
  Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Wisconsin Community - Based Research Consortium
Milwaukee,  Wisconsin,  53202
United States
 

Mem Hosp of Rhode Island
Pawtucket,  Rhode Island,  02860
United States
 

Davies Med Ctr
San Francisco,  California,  94114
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  212052196
United States
 

Univ TX San Antonio Health Science Ctr
San Antonio,  Texas,  78284
United States
 

Park Plaza Hosp
Houston,  Texas,  77004
United States
 

Boston City Hosp / FGH-1
Boston,  Massachusetts,  02118
United States
 

Infectious Disease Research Institute Inc
Tampa,  Florida,  33614
United States
 

Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles,  California,  90033
United States
 

East Orange Veterans Administration Med Ctr
East Orange,  New Jersey,  07018
United States
 

UCI Med Ctr
Orange,  California,  92668
United States
 

Buckley Braffman Stern Med Associates
Philadelphia,  Pennsylvania,  19107
United States
 


Additional Information:
Study ID Numbers:
  210A;  M/3330/0018
Study Start Date: 
Record last reviewed: November 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002322

Other Hiv Infections Studies:
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2. A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition

3. Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India

4. A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination with Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

5. Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328

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