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A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001010
First received: November 2, 1999
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Acyclovir
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Uncontrolled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Zidovudine (AZT) and Acyclovir (ACV) Given Concomitantly to Patients With Human Immunodeficiency Virus Infection

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 72
Study Completion Date: October 1990
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001010

Locations
United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Investigators
Study Chair: Corey L
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001010     History of Changes
Other Study ID Numbers: ACTG 010, 10986
Study First Received: November 2, 1999
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Immune Tolerance
Dose-Response Relationship, Drug
Drug Evaluation
Drug Therapy, Combination
Acyclovir
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Acyclovir
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014