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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

Page last updated: August 23, 2015

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