Clinical trial NCT00002440: A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official title: An Open-Label, Phase II Trial to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of 1592U89 in Combination With Selected HIV-1 Protease Inhibitors in Antiretroviral-Naive, HIV-1-Infected Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Mutation
HIV-1 Reverse Transcriptase
HIV Protease
Reverse Transcriptase Inhibitors
Anti-HIV Agents
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.

Detailed description: In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Local treatment for Kaposi's sarcoma.
* GM-CSF, G-CSF or erythropoietin.

Patients must have:

* HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture.
* CD4+ cell count \>= 100 cells/mm3 within 14 days of study drug administration.
* HIV-1 RNA \>= 5,000 copies/ml within 14 days of study drug administration.
* No active or ongoing AIDS-defining opportunistic infection or disease.
* Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Prior Medication:

Allowed:

Local treatment for Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication.
* Life-threatening infection or other serious medical condition that may compromise a patient's safety.

Concurrent Medication:

Excluded:

* Other investigational agents. NOTE:
* Those available through Treatment IND or expanded access programs are evaluated individually.
* Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma).
* Agents with documented anti-HIV activity in vitro.
* Foscarnet.
* Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons.
* Antioxidants.

Concurrent Treatment:

Excluded:

Radiation therapy within the first 24 weeks of study.

Patients with the following prior conditions are excluded:

* History of clinically relevant pancreatitis or hepatitis within the last 6 months.
* Participation in an investigational HIV-1 vaccine trial.

Prior Medication:

Excluded:

* Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy.
* Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
* HIV-1 vaccine dose within the 3 months prior to study drug administration.
* Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration.

Prior Treatment:

Excluded:

Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Treatment Ctr
state: California
city: New Haven
country: United States
facility: Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
state: Connecticut
city: Kansas City
country: United States
facility: Kansas City AIDS Research Consortium
state: Missouri
city: New York
country: United States
facility: NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial
state: New York
city: Charlotte
country: United States
facility: Carolinas Med Ctr
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve Univ / AIDS Clinical Trials Unit
state: Ohio
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh Med Ctr
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
Study officials:
References: