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AzTrials

HIV InfectionsPhase 2NCT00000712

A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3

A Phase 2 study testing Zidovudine and Acyclovir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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

Original design: The study's purpose is to compare the effects of zidovudine (AZT) alone to the combination of AZT and acyclovir (ACV) to determine if AZT/ACV is associated with a lower death rate and fewer AIDS related opportunistic infections compared to AZT alone, and to investigate the effect of these treatment… Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine and Acyclovir
How many people
400 participants
Where
8 sitesUnited States
Study dates
Start not givento Nov 1994
Phase
Phase 2
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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Methadone maintenance. Therapies available through expanded access or treatment IND programs unless specifically excluded.
  • Allowed within 30 days of study entry:
  • Systemic steroids only if given for treatment of Pneumocystis carinii pneumonia.
  • Recommended:
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  • PCP prophylaxis.
  • Patient must have:
  • Recovered from first episode of histologically proven Pneumocystis carinii pneumonia (PCP) or microbiologically proven AIDS-defining opportunistic infection as defined in Centers for Disease Control HIV classification group IV.
  • C-1.
  • Study entry must be within 120 days of AIDS-defining diagnosis.
  • Written documentation of positive antibody to HIV by any federally licensed ELISA test kit. This test should be confirmed by another method, for example, Western blot, radioimmunoassay (RIA), HIV culture.
  • Patients cannot be transfusion dependent (requiring blood transfusion more than once per month). The last transfusion must be > 2 weeks before entry.
  • AMENDED 90-08-27 to include HIV positive patients with CD4+ count < 200 cells/mm3.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT) for < 365 days prior to study entry.

Who cannot join

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Symptomatic visceral or progressive Kaposi's sarcoma (KS) (defined by > 10 new lesions in the 30 days prior to entry).
  • Other concurrent neoplasms other than basal cell carcinoma of skin (patients who have been in complete remission for 1 year for a malignancy may be enrolled).
  • Malabsorption as defined by persistent diarrhea > 6 stools/day for > 4 weeks. Patients whose sole AIDS-defining condition is constitutional disease as defined in CDC's HIV group IV-A or neurologic disease as defined in CDC's HIV group IV-B or AIDS-associated malignancies as defined in CDC's HIV group IV-C.
  • Concurrent Medication:
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  • Excluded:
  • Acyclovir (ACV) prophylaxis or frequent (> once per month) repeated courses of ACV therapy for herpes simplex virus infection.
  • Any concomitant medicine unless required.
  • Systemic therapy/prophylaxis/maintenance for AIDS-defining opportunistic infection other than prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Acetaminophen for > 72 hours. Cimetidine.
  • Flurazepam.
  • Indomethacin.
  • Ranitidine.
  • Probenecid (if receiving AZT).
  • Rifampin.
  • Rifampin-related drugs.
  • Patients with the following are excluded:
  • Active opportunistic infections.
  • Symptomatic visceral or progressive Kaposi's sarcoma (KS) (defined by > 10 new lesions in the 30 days prior to entry).
  • Other concurrent neoplasms other than basal cell carcinoma of skin (patients who have been in complete remission for 1 year for a malignancy may be enrolled).
  • Malabsorption as defined by persistent diarrhea > 6 stools/day for > 4 weeks.
  • Patients whose sole AIDS-defining condition is constitutional disease as defined in CDC's HIV group IV-A or neurologic disease as defined in CDC's HIV group IV-B or AIDS-associated malignancies as defined in CDC's HIV group IV-C.
  • Prior Medication:
  • Excluded:
  • Zidovudine (AZT) for > 365 days prior to study entry.
  • Excluded within 14 days of study entry:
  • Systemic acyclovir (ACV) therapy.
  • Excluded within 30 days of study entry:
  • Antiretroviral therapy (other than AZT per above).
  • Immunomodulating agents.
  • Biologic response modifiers.
  • Excluded within 60 days of study entry:
  • Ribavirin.
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Cytotoxic chemotherapy or radiation therapy for Kaposi's sarcoma.
  • Active substance abuse that would impair compliance with study procedure.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Bmc Actg Crs

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - East Campus A0102 CRS

    Boston, Massachusetts, 02215

  • Beth Israel Deaconess Med. Ctr., ACTG CRS

    Boston, Massachusetts, 02215

  • Unc Aids Crs

    Chapel Hill, North Carolina, 27599

  • Regional Center for Infectious Disease, Wendover Medical Center CRS

    Greensboro, North Carolina, 27401

  • University of Minnesota, ACTU

    Minneapolis, Minnesota, 55455

  • University of Washington AIDS CRS

    Seattle, Washington, 98122

  • Massachusetts General Hospital ACTG CRS

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Original design: The study's purpose is to compare the effects of zidovudine (AZT) alone to the combination of AZT and acyclovir (ACV) to determine if AZT/ACV is associated with a lower death rate and fewer AIDS related opportunistic infections compared to AZT alone, and to investigate the effect of these treatment plans on cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infections. The study evaluates two doses of AZT used alone versus two doses of AZT combined with ACV. Per 12/11/92 amendment: Another antiretroviral agent may be substituted for AZT.

AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related complex and patients being treated for Pneumocystis carinii pneumonia. Drugs that increase the effectiveness of AZT against HIV may also decrease the need for high doses of AZT. This might reduce some of the negative effects of AZT while not reducing the positive effects.

Read the detailed description

AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related complex and patients being treated for Pneumocystis carinii pneumonia. Drugs that increase the effectiveness of AZT against HIV may also decrease the need for high doses of AZT. This might reduce some of the negative effects of AZT while not reducing the positive effects.

AMENDED: Patients are randomly assigned to one of two treatment regimens. They receive AZT (or other antiretroviral agent) with or without ACV. Treatment Plan 1: AZT along with placebo at the same time. Treatment Plan 2: AZT and ACV. Therapy is for 104 weeks with an optional extension of 24 weeks or until the end of the study whichever comes first. The maximum duration of therapy for any patient will be 128 weeks. Medication is dispensed on a biweekly basis for the first 4 weeks, then every other month for the remainder of the study. Original design: Patients are randomly assigned to one of four treatment plans to receive AZT alone or AZT and ACV. Medications are given every 4 hours (q4h) orally (PO) while awake (WA). A total of 5 doses/day are given. The per dose schedule for the four plans are: Treatment plan 1: AZT plus placebo (an inactive medication) substituting for ACV. Treatment plan 2: AZT and AZT placebo along with an ACV placebo. Treatment plan 3: AZT and ACV. Treatment plan 4: AZT and AZT placebo and ACV.

Conditions
HIV Infections
Being tested
Zidovudine, Acyclovir
Keywords
AIDS-Related Opportunistic Infections, Herpesviridae Infections, Drug Evaluation, Drug Therapy, Combination, Herpesvirus 4, Human, Cytomegalovirus Infections, Acyclovir, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine
Medical subject headings
HIV Infections, AIDS-Related Opportunistic Infections, Herpesviridae Infections, Epstein-Barr Virus Infections, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

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 completionNov 1994

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 2
Primary purpose
Treatment
Intervention model
Parallel groups
Enrolment
400 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000712
Sponsor's protocol ID
ACTG 063
Other IDs
11037
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Collier AC, Schoenfeld DA, Bourland D, Hirsch M, Davis LG, Corey L. Prospective comparative study of acyclovir (ACV) and zidovudine (ZDV) versus ZDV alone in patients with AIDS. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2;125

  • 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 2 study testing Zidovudine and Acyclovir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 17 inclusion and 38 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 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT00000712, which also lists 2 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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