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Herpes SimplexPhase 3NCT00000985

Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir

A Phase 3 study testing Vidarabine, Acyclovir and Foscarnet sodium in people with Herpes Simplex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 safety and effectiveness of foscarnet and vidarabine treatments for AIDS patients who have herpes simplex virus infections that are resistant to standard treatment with acyclovir. Read more about this study

Who is it for?
Ages 13 to 65 years
Conditions the study is for
Herpes Simplex, HIV Infections
What is being tested?
Vidarabine, Acyclovir and Foscarnet sodium
How many people
26 participants
Where
4 sitesUnited States
Study dates
Start not givento Oct 1990
Phase
Phase 3
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Allowed for phase B:
  • Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Prior Medication:
  • Allowed for phase A:
  • Ganciclovir. Patients receiving this drug at the time of study enrollment must discontinue the drug at the time of enrollment and for the duration of the study period.

Who cannot join

  • Co-existing Condition:
  • For phase A, patients with pre-existing severe neurologic impairment such as seizure disorder or marked or incapacitating ataxia are excluded.
  • Concurrent Medication:
  • Excluded upon entry into phase B:
  • Ganciclovir.
  • Immunomodulators.
Show all 41Show fewer
  • Probenecid.
  • Ciprofloxacin.
  • Allopurinol.
  • Zidovudine (AZT).
  • Antiretrovirals.
  • Other investigational agents.
  • Acyclovir for another labeled indication.
  • Potentially nephrotoxic agents.
  • Patients will be excluded from the study for the following reasons:
  • Phase A:
  • Previous hypersensitivity reaction to foscarnet or vidarabine. Patients who have a documented history of vidarabine intolerance may be eligible for the foscarnet on the non-randomized arm of the study.
  • Phase B:
  • Clinical response to therapy with acyclovir in phase A described as "healed" or "good."
  • Prior Medication:
  • Excluded within 14 days of study entry:
  • Immunomodulators or biologic response modifiers.
  • Phase A:
  • Excluded within 30 days of study entry:
  • Foscarnet.
  • Phase B:
  • Excluded within 7 days of study entry into phase B:
  • Any potentially nephrotoxic agent, except acyclovir.
  • Prior Treatment:
  • Excluded for phase A within 14 days of study entry:
  • Lymphocyte replacement therapy.
  • Patients must demonstrate the following clinical and laboratory findings:
  • Phase A:
  • HIV positive by federally licensed ELISA test confirmed by Western blot, p24 serum antigen, or a positive HIV culture; or a prior diagnosis of AIDS as defined by Centers for Disease Control criteria.
  • Mucocutaneous herpes simplex virus (HSV) infection confirmed by viral culture persisting for a minimum of 2 weeks which is clinically resistant to therapy with acyclovir in the opinion of the patient's physician.
  • Phase B:
  • Persistent shedding of HSV at the completion of or within 1 week after completion of phase A acyclovir therapy as confirmed by viral culture.
  • Documented in vitro resistance of the virus to acyclovir.
  • All strains must be referred to the Diagnostic Virology Laboratories at either San Francisco General Hospital or Beth Israel Hospital, Boston, for susceptibility testing.
  • Two serum acyclovir levels drawn during phase A. Results may be pending at time of entry into phase B.
  • All eligibility evaluations must be performed within 7 days prior to study entry for phase A or B.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Beth Israel Deaconess - East Campus A0102 CRS

    Boston, Massachusetts, 02215

  • Rush Univ. Med. Ctr. ACTG CRS

    Chicago, Illinois, 60612

  • Univ. of Rochester ACTG CRS

    Rochester, New York

  • University of Washington AIDS CRS

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Infection in Patients With the Acquired Immunodeficiency Syndrome: A Randomized Multicenter Study of Foscarnet Versus Vidarabine

To compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS patients who have herpes simplex virus infections that are resistant to standard treatment with acyclovir.

Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS. Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS, but it has not been studied in patients who do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further progression of the herpes simplex infection and may have fewer side effects.

Read the detailed description

Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS. Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS, but it has not been studied in patients who do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further progression of the herpes simplex infection and may have fewer side effects.

Following evaluation studies, patients receive at least 10 days of intravenous (IV) therapy with acyclovir. During this therapy, patients have two serum concentration levels of acyclovir drawn to make sure there are adequate levels of medication in their blood. If skin lesions do not heal after a total of 10 days of therapy with acyclovir, lesions are swabbed for viral culture to test the susceptibility of the virus to therapy with acyclovir, foscarnet, and vidarabine. If the test confirms that the herpes lesions are resistant to acyclovir, patients may choose to participate in the next phase of the study. Following additional evaluation studies, patients are randomized to one of two groups, each of which receives 10-21 days of IV treatment with one of the two alternative medications, foscarnet or vidarabine. Foscarnet is given by IV infusion every 8 hours, and each infusion lasts 1 hour. Vidarabine is given by IV infusion once a day, and each infusion lasts 12 hours. While receiving therapy with either foscarnet or vidarabine, blood tests are done every 3 days for routine lab tests and once a week to determine foscarnet or vidarabine blood levels. Skin lesions are cultured for herpes virus every 5 days. At the end of 10 days of therapy, improvement is evaluated, and the patients can continue to receive therapy if indicated. There is a provision for cross-over treatment if patients show a poor response.

Being tested
Vidarabine, Acyclovir, Foscarnet sodium
Keywords
Vidarabine, Phosphonoacetic Acid, Herpes Simplex, Foscarnet, Acyclovir, Acquired Immunodeficiency Syndrome
Medical subject headings
Herpes Simplex, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

  • VidarabineDrug

  • AcyclovirDrug

  • Foscarnet sodiumDrug

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 3
Primary purpose
Treatment
Intervention model
Parallel groups
Enrolment
26 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000985
Sponsor's protocol ID
ACTG 095
Other IDs
11070
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Safrin S, Crumpacker C, Chatis P, Davis R, Hafner R, Rush J, Kessler HA, Landry B, Mills J. A controlled trial comparing foscarnet with vidarabine for acyclovir-resistant mucocutaneous herpes simplex in the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. N Engl J Med. 1991 Aug 22;325(8):551-5. doi: 10.1056/NEJM199108223250805.

    PubMed 1649971

  • Safrin S, Crumpacker C, Chatis P, Davis R, Hafner R, Rush J, Kessler H, Landry B, Mills J. ACTG 095: a randomized comparison of foscarnet (FOS) vs. Vidarabine (ARA-A) for treatment of acyclovir (ACV)-resistant mucocutaneous herpes simplex virus (HSV) infection in patients with AIDS. Int Conf AIDS. 1991 Jun 16-21;7(1):44 (abstract no MB85)

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vidarabine, Acyclovir and Foscarnet sodium in people with Herpes Simplex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 6 inclusion and 41 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 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 NCT00000985, 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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