NCT00001010

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

October 1, 1990

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Immune ToleranceDose-Response Relationship, DrugDrug EvaluationDrug Therapy, CombinationAcyclovirAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudine

Interventions

ZidovudineDRUG
AcyclovirDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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:
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

Univ of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (5)

  • Collier AC, Bozzette S, Coombs RW, Causey DM, Schoenfeld DA, Spector SA, Pettinelli CB, Davies G, Richman DD, Leedom JM, et al. A pilot study of low-dose zidovudine in human immunodeficiency virus infection. N Engl J Med. 1990 Oct 11;323(15):1015-21. doi: 10.1056/NEJM199010113231502.

    PMID: 1977080BACKGROUND

  • ICDB/90665116. Collier A, et al. Virologic and clinical response to combination zidovudine (AZT) and acyclovir (ACV) in AIDS-related complex (ARC). Twenty-ninth Intersci Conf Antimicro Agts and Chemother. 1989 Sep 17-20; 105

    BACKGROUND

  • Coombs RW, Collier AC, Chaloupka K, Corey L. Decreased HIV plasma titer in response to combined low-dose zidovudine and acyclovir therapy in CDC class IVA patients. Int Conf AIDS. 1990 Jun 20-23;6(1):139 (abstract no ThB24)

    BACKGROUND

  • Tartaglione TA, Collier AC, Opheim K, Gianola FG, Benedetti J, Corey L. Pharmacokinetic evaluations of low- and high-dose zidovudine plus high-dose acyclovir in patients with symptomatic human immunodeficiency virus infection. Antimicrob Agents Chemother. 1991 Nov;35(11):2225-31. doi: 10.1128/AAC.35.11.2225.

    PMID: 1803995BACKGROUND

  • Ioannidis JP, Collier AC, Cooper DA, Corey L, Fiddian AP, Gazzard BG, Griffiths PD, Contopoulos-Ioannidis DG, Lau J, Pavia AT, Saag MS, Spruance SL, Youle MS. Clinical efficacy of high-dose acyclovir in patients with human immunodeficiency virus infection: a meta-analysis of randomized individual patient data. J Infect Dis. 1998 Aug;178(2):349-59. doi: 10.1086/515621.

    PMID: 9697714BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

ZidovudineAcyclovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Corey L

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

October 1, 1990

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(3)