Clinical trial NCT00002207: A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients
Official title: A Randomized, Double-Blind Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination With Twice-Daily Dosing of Stavudine in HIV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Didanosine
Drug Therapy, Combination
Stavudine
Reverse Transcriptase Inhibitors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinsites / Sorra Research Ctr
state: Alabama
city: Tarzana
country: United States
facility: Shared Med Research Foundation
state: California
city: Indianapolis
country: United States
facility: Indiana Univ School of Medicine / Dept of Infect Dis
state: Indiana
city: Ypsilanti
country: United States
facility: Medicine Faculty Associates
state: Michigan
city: Newark
country: United States
facility: New Jersey Community Research Initiative
state: New Jersey
city: Somerville
country: United States
facility: ID Care Inc
state: New Jersey
city: Portland
country: United States
facility: Fanno Creek Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Galveston
country: United States
facility: Univ of Texas Med Branch
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
city: Richmond
country: United States
facility: Dr Iraj Mirshahi
state: Virginia
Study officials:
References:
citation: Mobley JE, Pollard RB, Schrader S, Adler MH, Kelleher T, McLaren C. Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine. AI454-143 Team. AIDS. 1999 Jul 30;13(11):F87-93. doi: 10.1097/00002030-199907300-00003.