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Trial record 42 of 115 for:    acyclovir

A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

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ClinicalTrials.gov Identifier: NCT00001010
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date March 16, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00001010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
Official Title  ICMJE An Uncontrolled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Zidovudine (AZT) and Acyclovir (ACV) Given Concomitantly to Patients With Human Immunodeficiency Virus Infection
Brief Summary To compare the effect of zidovudine (AZT) given alone with the combination of AZT and acyclovir (ACV) on the human immunodeficiency virus (HIV) in persons infected with HIV, and to study the pharmacokinetics (how fast AZT reaches certain levels in blood and how long it remains), safety, and effectiveness of AZT given alone and in combination with ACV in treating HIV-infected patients. Other studies have shown that AZT offers potential benefits to specific AIDS patients when given over long time periods, and experiments in vitro (in the test tube) suggest that ACV may stimulate the action of AZT against HIV. It is necessary to obtain information on how these drugs perform in HIV-infected humans.
Detailed Description

Other studies have shown that AZT offers potential benefits to specific AIDS patients when given over long time periods, and experiments in vitro (in the test tube) suggest that ACV may stimulate the action of AZT against HIV. It is necessary to obtain information on how these drugs perform in HIV-infected humans.

The first 12 patients will take AZT capsules every 4 hours, and 6 of the patients will also take ACV 6 times a day. Later groups of patients will receive higher doses of AZT if the earlier doses are tolerated without significant adverse effect. It was initially planned to stop treatment after 12 weeks, but if the first 10 patients who have entered the study have tolerated treatment well, the duration of treatment will be extended with a crossover in dosage. The treatment may be lifelong, depending on the results obtained with regard to safety and effectiveness of the drugs. Blood and urine samples will be obtained periodically in order to estimate blood levels of the drugs, to study the excretion of the drugs, and to determine the effects of the drugs on HIV and on the immune system and medical condition of the patient.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Zidovudine
  • Drug: Acyclovir
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
72
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1990
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Exclusion Criteria

  • Active drug or alcohol abuse.

Concurrent Medication:

Excluded:

  • Any chronic systemic medications.
  • Aspirin.
  • Cimetidine.
  • Flurazepam.
  • Indomethacin.
  • Ranitidine.
  • Probenecid.
  • Excluded during first 2 weeks of study:
  • Any chronic ( > 3 days) medication.
  • Acetaminophen and other drugs that are metabolized by hepatic glucuronidation.

Prior Medication:

Excluded:

  • Zidovudine (AZT) at any time.
  • Excluded within 14 days of study entry:
  • Other experimental therapy.
  • Drugs which cause neutropenia or significant nephrotoxicity.
  • Rifampin or rifampin derivatives.
  • Systemic anti-infectives.
  • Excluded within 30 days of study entry:
  • Immunomodulating agents.
  • Excluded within 3 months of study entry:
  • Any antiretroviral agent.

Patients may not have any of the following:

  • A gastrointestinal disturbance which may impair oral absorption.
  • Chronic persistent candidiasis.
  • An opportunistic infection or malignancy fulfilling the definition of AIDS-associated disease.
  • Patients with symptoms suggestive of an opportunistic infection should be evaluated within 30 days of starting drug.

Patients may not have any of the following:

  • A gastrointestinal disturbance which may impair oral absorption.
  • Chronic persistent candidiasis.
  • An opportunistic infection or malignancy fulfilling the definition of AIDS-associated disease.
  • Patients with symptoms suggestive of an opportunistic infection should be evaluated within 30 days of starting drug.

All patients will have positive antibody for HIV confirmed by any federally licensed ELISA test kit; if ELISA is negative, eligibility will be confirmed by a positive Western blot.

  • All patients will have evidence of HIV infection in the plasma as indicated by circulatory p24 antigen within 30 days prior to study entry.
  • The symptomatic HIV infection required for inclusion is defined as at least one of the following:
  • Temperature > 38.0 degrees C persisting for more than 14 consecutive days or more than 15 days in a 30-day interval prior to study entry without definable cause.
  • Diarrhea, defined as = or > 3 liquid stools per day, persisting for more than 1 month prior to entry into the study without definable cause.
  • Weight loss greater than 10 percent of body weight noted in a 120-day period prior to entry into the study.
  • Patients with persistent generalized lymphadenopathy (PGL), defined as lymph node enlargement greater than 1 cm in diameter at two or more noncontiguous extrainguinal sites, who in addition to this adenopathy have constitutional symptoms such as intermittent fever (> 38 degrees C for less than 15 days/month), sweats, malaise, and/or fatigue will also be eligible. This patient population has to have T4 cell counts = or < 500. Potential enrollees with PGL must have two screening lymphocyte subset determinations, at least 72 hours apart, within 3 months of entry that fall in the appropriate T4 range (200 - 500 cells/mm3). If an otherwise eligible subject has one screening T4 count in the appropriate range and one that is outside this range, a third screening count will determine eligibility.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00001010
Other Study ID Numbers  ICMJE ACTG 010
10986 ( Registry Identifier: DAIDS ES Registry Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Corey L
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP