The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Indinavir sulfate  Drug: Ritonavir  Drug: Lamivudine  Drug: Stavudine	Phase II

Further Study Details: 

Expected Total Enrollment:  8

Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.

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

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Are at least 18 years old.
• Have a viral load of 5,000 copies/ml or greater.
• Have a CD4 count of at least 50 cells/mm3.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have taken any antiretroviral (anti-HIV) agent.
• Are pregnant.

Florida
      Univ of Miami School of Medicine, Miami,  Florida,  33136,  United States
New York
      Albany Med College, Albany,  New York,  12208,  United States
      SUNY at Stony Brook / Division of Infectious Diseases, Stony Brook,  New York,  11794,  United States

Study ID Numbers:  246U; 104-00
Record last reviewed:  July 2002
Last Updated:  October 13, 2004
Record first received:  January 17, 2000
ClinicalTrials.gov Identifier:  NCT00002451
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08