A Randomized, Double-Blind Study of MKC-442 Combined With Viracept in Patients Who Are Epivir + Retrovir Experienced and Are Protease Inhibitor- and Non-Nucleoside Reverse Transcriptase Inhibitor-Naive
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
To compare the proportion of patients whose plasma HIV-1 RNA level falls and remains below the limit of quantification by the Roche Amplicor Monitor (400 copies/ml)\[AS PER AMENDMENT 8/4/98: 50 copies/ml\] between weeks 0 and 24. To determine the short-term safety and tolerability of MKC-442 plus nelfinavir (Viracept) plus dual nucleoside analogs. To determine the time to viral failure and time to tolerability failure through Week 48 of therapy.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Required:
- At least 1 different nucleoside analog, e.g., 3TC, d4T, or ddI (excluding zidovudine).
- Allowed:
- Chemoprophylaxis for Pneumocystis carinii pneumonia.
- Short courses (less than 21 days) of acyclovir for acute treatment.
- Recombinant erythropoietin or G-CSF for Grade 3 or greater anemia and neutropenia, respectively.
- Allowed only with caution and close patient monitoring:
- Ketoconazole, fluconazole, itraconazole, and grapefruit juice.
- Medications metabolized by cytochrome P450.
- Oral contraceptives, contraceptive implants such as Norplant, or injection-type contraceptives such as Depo-Provera only if not sole method of contraception.
- Patients may have:
- HIV-1 RNA greater than 10,000.
- No active AIDS-defining illnesses.
- Prior experience with 2 nucleoside analogues and able to switch to at least 1 different non-nucleoside analog, e.g., lamivudine (3TC), stavudine (d4T), or didanosine (ddI) with HIV-1 RNA 10,000 copies/ml or less. \[AS PER:
- +7 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Active AIDS-defining illnesses.
- Malabsorption syndrome or severe chronic diarrhea within 30 days of entry, or inability to consume adequate oral intake due to chronic nausea, emesis, or abdominal or esophageal discomfort. \[AS PER AMENDMENT 8/4/98\].
- Inadequately controlled seizure disorder \[AS PER AMENDMENT 8/4/98\].
- Any intercurrent illness that could affect viral load determination \[AS PER AMENDMENT 8/4/98\].
- Concurrent Medication:
- Excluded:
- Zidovudine.
- Immunomodulators (e.g., systemic corticosteroids, interleukin-2, or interferons). \[AS PER AMENDMENT 8/4/98\].
- Rifampin, rifabutin, phenobarbital, and hydantoin.
- Amiodarone, quinidine, astemizole, terfenadine, ergot derivatives, midazolam, triazolam, and cisapride.
- Neurotoxic agents (e.g., vincristine, thalidomide). \[AS PER AMENDMENT 8/4/98\].
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-04