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Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E



Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E

For Condition: HIV Infections
Status: Completed
Sponsor(s): Pharmacia and Upjohn ,
Synopsis: To determine the time course of development of resistance to atevirdine mesylate ( U-87201E ) in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to U-87201E. To determine the genotype and phenotype effects of treatment with a nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in the presence of U-87201E will generate the resistant mutants that may subsequently emerge in the patients.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Enrollment on protocol RV-43 (AZT resistance study). - Development of a primary RV-43 study endpoint-opportunistic infection. - HIV isolate with an AZT IC50 > 50 times that of the sensitive type strain. - Able to swallow tablets without difficulty. - Normal QTc interval on EKG. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine). - Severe uncontrollable diarrhea or vomiting or known malabsorption. - Symptomatic hyperlipidemia. Concurrent Medication: Excluded: - Other experimental drugs. - AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted). Patients with the following prior conditions are excluded: History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction. Prior Medication: Excluded: - Experimental drugs within 4 weeks prior to study entry.
Total Enrollment: 

Location and Contact Information:

Natl Naval Med Ctr
Bethesda,  Maryland,  208995000
United States
 


Additional Information:
Study ID Numbers:
  117A;  M/3330/0007
Study Start Date: 
Record last reviewed: February 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002094

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2. An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent

3. A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy

4. Safety and Effectiveness of PEG-Intron in HIV-Infected Patients

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Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E

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