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).

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Indinavir sulfate  Drug: Nelfinavir mesylate  Drug: Efavirenz	Phase II

Further Study Details: 

Expected Total Enrollment:  6

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  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.

California
      Pacific Oaks Med Group, Beverly Hills,  California,  90211,  United States
Colorado
      Univ of Colorado / Health Science Ctr, Denver,  Colorado,  80262,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Rhode Island
      Brown Univ School of Medicine, Providence,  Rhode Island,  02908,  United States
Virginia
      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  United States

Study ID Numbers:  259G; ICC 602
Record last reviewed:  March 2000
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002235
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08