A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients

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Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Stavudine
Drug: Didanosine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002207
039D
AI454-143

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.

Full description

Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4 cell count of at least 100 cells/mm3.
  • Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

  • Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
  • Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening.
  • Inability to tolerate oral medication.
  • Any other clinical condition that would preclude compliance with dosing requirements.

Patients with the following prior conditions are excluded:

  • History of acute or chronic pancreatitis.
  • Intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry.

Proven or suspected acute hepatitis within 30 days prior to study entry.

1. Potent neurotoxic drugs, such as vincristine and thalidomide.

Other anti-HIV therapy.

1. Prophylaxis for pneumocystis carinii pneumonia (PCP) is strongly recommended for patients with CD4 cell counts less than or equal to 200/mm3 or who have had a prior episode of PCP.

Immunizations recommended by ACIP for routine practice.

Erythropoietin and G-CSF are allowed if myelosuppression emerges on study.

1. Any antiretroviral therapy.

Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.

1. Any prior antiretroviral therapy.

Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.

Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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