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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002235
• Date of registration: 02/11/1999
• Primary sponsor: Merck
• Public title: 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
• Scientific 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
• Date of first enrolment: March 1999
• Target sample size: 6
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002235
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Efavirenz

Drug: Indinavir sulfate

Drug: Nelfinavir mesylate

Secondary ID(s)

259G

ICC 602

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Agouron Pharmaceuticals