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HIV InfectionsPhase 1NCT00000988

A Study of BMY-27857 in Patients With AIDS or AIDS Related Complex

A Phase 1 study testing Stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or AIDS related complex (ARC). To establish an appropriate dosage regimen of d4T to be employed in Phase II and III trials. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Stavudine
How many people
40 participants
Where
2 sitesUnited States
Study dates
Start not givento not given
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis.
  • TMP/SMX as an alternative prophylactic agent, 1 DS tablet orally per day.
  • Acute therapy with oral acyclovir for herpes simplex infections for no more than 7 days, providing d4t is suspended Symptomatic therapy such as analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy may be administered for toxicities as deemed necessary by the principal investigator. For therapy of fever, aspirin rather than acetaminophen should be used.
  • Concurrent Treatment:
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  • Allowed:
  • Transfusion of up to 2 units of packed red blood cells every 3 weeks for grade 3 or grade 4 anemia (see Recommendations for Grading of Acute and Subacute Toxic Effects (Adults)) until patient returns to baseline from grade 3 or to baseline or grade 1 from grade 4.
  • Patient must have:
  • AIDS or AIDS related complex (CDC Group IVA or CDC Group IVC-2 with thrush or oral leukoplakia).
  • Ability to provide informed consent.
  • Availability to follow-up for at least 6 months.
  • Absence of active, AIDS-defining opportunistic infection on study entry.

Who cannot join

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Active, AIDS-defining opportunistic infection.
  • Intractable diarrhea.
  • History or propensity for seizure disorders requiring anticonvulsants for control.
  • Any other clinical condition which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
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  • Concurrent Medication:
  • Excluded:
  • Systemic therapy with this or any other antiretroviral drug (including AL-721, ddI, ddC, interferon, immunomodulating drugs) or investigational drug.
  • Ribavirin.
  • Cytotoxic anticancer therapy.
  • Therapy with any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes, such as rifampin or barbiturates.
  • Systemic maintenance or chemoprophylaxis for opportunistic infections.
  • Trimethoprim / sulfamethoxazole for Pneumocystis carinii infections.
  • Acute therapy with ketoconazole for thrush.
  • Neurotoxic agents listed in the protocol.
  • Patients with the following are excluded:
  • Previous intolerance to zidovudine (AZT) as demonstrated by transfusion dependent anemia (transfusion required every 3 weeks or less and AZT-related depression of neutrophils to < 500 cells/mm3).
  • Life expectancy < 6 months.
  • Prior Medication:
  • Excluded:
  • Any other prior therapy which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
  • Excluded within 2 weeks of study entry:
  • Therapy with any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes, such as rifampin or barbiturates.
  • Excluded within 1 month of study entry:
  • Systemic therapy with this or any other antiretroviral drug (including AL-721, interferon, immunomodulating drugs, ddI, ddC) or any investigational drug.
  • Excluded within 3 months of study entry:
  • Ribavirin.
  • Cytotoxic anticancer therapy.
  • Prior Treatment:
  • Excluded:
  • Any prior therapy which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
  • Preference:
  • Tolerating zidovudine (AZT) at time of study entry.
  • Active alcohol or drug abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cornell Univ Med Ctr

    New York, New York, 10021

  • Mount Sinai Med Ctr

    New York, New York, 10029

Other trials in United States

About this study

Official title: A Phase I Safety and Pharmacokinetics Study of BMY-27857 (2',3'-Didehydro-3'-Deoxythymidine) Administered Twice Daily to Patients With AIDS or AIDS Related Complex

To evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or AIDS related complex (ARC). To establish an appropriate dosage regimen of d4T to be employed in Phase II and III trials. To evaluate the effects of de-escalating doses of d4T on markers associated with HIV infection.

Currently, the only FDA-approved therapy for patients with AIDS or ARC is zidovudine (AZT), a drug with significant value but limited use because of toxic effects on the bone marrow. d4T has not been tested in humans, but it has inhibited the reproduction of HIV (the virus that causes AIDS) in laboratory experiments. In some studies with laboratory animals, d4T was less toxic against blood cells than AZT.

Read the detailed description

Currently, the only FDA-approved therapy for patients with AIDS or ARC is zidovudine (AZT), a drug with significant value but limited use because of toxic effects on the bone marrow. d4T has not been tested in humans, but it has inhibited the reproduction of HIV (the virus that causes AIDS) in laboratory experiments. In some studies with laboratory animals, d4T was less toxic against blood cells than AZT.

A maximum tolerated dose (MTD) has been found in Phase I trials to date. An MED will be determined. The daily dose of d4T is divided into 2 portions and administered approximately 12 hours apart for 10 weeks. 5 patients receive the initial dose level and successive groups of 5 patients enter the study at a lower dose level once 3 patients in the preceding group have successfully completed at least 3 weeks of dosing and shown a positive effect on CD4 cell count and p24 antigen levels. The initial group of patients continue dosing at their dose level for an additional 94 weeks as long as they are doing well as measured by p24 antigen levels and CD4 cell counts. The dose de-escalation scheme continues until a lack of efficacy is seen in 2 of 5 patients in any group. Patients are assigned to de-escalating dose level treatment groups in the order in which they are enrolled. Blood and urine samples are taken regularly to check for toxic effects and therapeutic effectiveness. In each dosing group, 3 of 5 patients will be p24 antigen positive greater than or equal to 70 pg/ml, and 2 of 5 patients will have CDC-defined AIDS.

Conditions
HIV Infections
Being tested
Stavudine
Keywords
Injections, Intravenous, Drug Evaluation, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
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.

  • StavudineDrug

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)

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
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000988
Sponsor's protocol ID
ACTG 089
Other IDs
AI455-002, 070V3
Status last verified
Dec 1994
First submitted
2 Nov 1999
Last updated
26 Aug 2008
Results posted
No

Publications

  • Murray HW, Squires KE, Weiss W, Sledz S, Sacks HS, Hassett J, Cross A, Anderson RE, Dunkle LM. Stavudine in patients with AIDS and AIDS-related complex: AIDS clinical trials group 089. J Infect Dis. 1995 Mar;171 Suppl 2:S123-30. doi: 10.1093/infdis/171.supplement_2.s123.

    PubMed 7861017

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 13 inclusion and 35 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 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 NCT00000988, which also lists 1 linked publication.

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 26 Aug 2008.

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