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AzTrials

HIV InfectionsPhase 1NCT00001010

A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

A Phase 1 study testing Zidovudine and Acyclovir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine and Acyclovir
How many people
72 participants
Where
3 sitesUnited States
Study dates
Start not givento Oct 1990
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Active drug or alcohol abuse.
  • Concurrent Medication:
  • Excluded:
  • Any chronic systemic medications.
  • Aspirin.
  • Cimetidine.
Show all 42Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • Univ of Washington

    Seattle, Washington, 98105

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Being tested
Zidovudine, Acyclovir
Keywords
Immune Tolerance, Dose-Response Relationship, Drug, Drug Evaluation, Drug Therapy, Combination, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionOct 1990

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
72 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001010
Sponsor's protocol ID
ACTG 010
Other IDs
10986
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 1977080

  • 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

  • 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)

  • 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.

    PubMed 1803995

  • 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.

    PubMed 9697714

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zidovudine and Acyclovir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001010, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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