A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Nelfinavir mesylate (Drug); Efavirenz (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
Indinavir is usually taken three times a day. The purpose of this study is to see if it is
safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a
day) and efavirenz (taken once a day).
Clinical Details
Official title: A Phase II, 48-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of a Simplified Dosing Regimen of Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor and Protease Inhibitor Naive Patients
Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
Detailed description:
Patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for
48 weeks. During the study, patients are evaluated for changes from baseline in plasma
HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and
toxicities. After Week 48, patients with documented virologic response are eligible to
continue receiving study treatments and to attend scheduled follow-up visits. Patients who
experience virologic failure are discontinued from the study.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Have a viral load of at least 10,000 copies/ml within 30 days of study entry.
- Agree to use a barrier method of birth control, such as condoms, during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have hepatitis.
- Have any other serious medical condition besides HIV infection.
- Are allergic to indinavir, nelfinavir, or efavirenz.
- Have ever taken NNRTIs or protease inhibitors.
- Have had chemotherapy or radiation therapy within 30 days of study entry. (Local
radiation therapy is allowed.)
- Have taken certain other medications that might affect your immune system such as
interleukin-2, interferon, or a vaccine within 30 days of study entry.
- Are enrolled or plan to enroll in another anti-HIV drug study during this study.
- Are pregnant or breast-feeding.
- Abuse alcohol or drugs.
Locations and Contacts
Pacific Oaks Med Group, Beverly Hills, California 90211, United States
Univ of Colorado / Health Science Ctr, Denver, Colorado 80262, United States
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
Brown Univ School of Medicine, Providence, Rhode Island 02908, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States
Additional Information
Last updated: June 23, 2005
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