The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Emivirine  Drug: Hydroxyurea  Drug: Nevirapine  Drug: Stavudine  Drug: Didanosine	Phase II

Further Study Details: 

Expected Total Enrollment:  25

Patients receive a regimen of didanosine, stavudine, nevirapine, and MKC-442 for 24 weeks. Throughout 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. Patients who experience virologic failure have the option of adding hydroxyurea to their treatment regimen or discontinuing from the study. After Week 24, patients with documented virologic response may continue treatment with didanosine, stavudine, nevirapine, and MKC-442, and, if applicable, hydroxyurea until a change in virologic status occurs (i.e., the patient experiences virologic failure). Follow-up visits are conducted every 4 to 12 weeks until permanent discontinuation from the study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are at least 18 years old.
• Are HIV-positive.
• Have experienced treatment failure on a previous anti-HIV drug combination that contained at least one protease inhibitor. Your viral load must be between 5,000 and 50,000 copies/ml after 6 months of continuous treatment with that drug combination.
• 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 a history of certain serious medical conditions, including pancreatitis, neuropathy, untreated seizures, or AIDS-related cancers, except Kaposi's sarcoma (KS).
• Are enrolled in another anti-HIV drug study while participating in this study.
• Have ever taken NNRTIs (such as NVP or MKC-442).
• Have ever taken ddI or d4T.
• Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system (such as corticosteroids, interleukin-2, or interferon).
• Abuse alcohol or drugs.
• Have received chemotherapy or radiation therapy within 30 days prior to study entry. (Local radiation therapy is allowed.)
• Are allergic to any of the study drugs.
• Are pregnant or breast-feeding.

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:  292D; ICC 601
Record last reviewed:  March 2000
Last Updated:  October 27, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002418
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08