This study is for patients with HIV-1 who have not been previously treated with medications for HIV (antiretroviral drugs). The main purpose of this study is to find out how effective different drug combinations are in decreasing viral load (amount of HIV virus detected in blood). Participants in this study will be randomly divided into two groups. One group will be given saquinavir/ritonavir twice a day combined with emtricitabine/tenofovir once a day. The other group will receive lopinavir/ritonavir twice a day combined with emtricitabine/tenofovir once a day. Patients selected to participate in this study are required to return to the clinic for checkups at weeks 2,4,8,12,16, 20, 24, 36, 48 and 52 (follow-up).

Another purpose of this study is to look at the safety (absence of harmful side effects), adherence (ability of patients to comply with treatment), and tolerability(ability of patients to tolerate side effects) of saquinavir/ritonavir taken twice a day in combination with emtricitabine/tenofovir taken once daily compared to lopinavir/ritonavir taken twice a day in combination with emtricitabine/tenofovir taken once daily in patients not previously treated with antiretrovirals (medications that treat HIV).

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: saquinavir mesylate	Phase IV

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

Criteria

Inclusion Criteria:

• 18 years old and older
• Male patients
• Females who are not pregnant
• Females who are not breast feeding
• Positive blood test for HIV-1
• HIV-1 RNA viral load greater than 10,000 copies/mL (determined by blood test)
• Patients with any CD4+ count that requires treatment in the opinion of the investigator, the researcher in charge of the study at the trial site, are eligible. Patients with a CD4+ count greater than 350 must have an HIV-1 RNA viral load greater than 100,000 copies/mL. (determined by blood test).
• No previous treatment with drugs used to treat HIV (antiretroviral drugs). Less than two weeks of antiretroviral treatment is considered as no treatment.
• Ability and willingness to provide written informed consent
• Ability and willingness stay on the course of therapy required by the study
• Females of childbearing potential --Must not be pregnant, this must be confirmed by a negative pregnancy test before the start of the study --Must be using 2 reliable forms of contraception, including a barrier method (example of barrier method is a condom or diaphragm) --Must agree to continue using 2 reliable forms of contraception, including a barrier method (condom is a barrier method) for the duration of the study and for 90 days after the last dose of study medication.

Exclusion Criteria:

• Previous treatment with drugs used to treat HIV (antiretroviral drugs). Two weeks or more of antiretroviral treatment is considered as treatment.
• Patients with a CD4+ count greater than 350 and HIV-1 RNA viral load less than 100,000 copies/mL (determined by blood test)
• Females who are pregnant
• Females who are breast-feeding
• Females who plan to become pregnant during the study
• Females who plan to breast-feed during the study
• Patients with active hepatitis B infection (determined by blood test)
• Patients with poorly functioning kidneys (determined by blood test)
• Patients with poor liver function, (determined by blood test)
• Patients with who have cirrhosis of the liver
• Patients who had received an investigational new drug within the last 4 weeks
• Patients who are currently taking, or plan to take during the course of the study, any drug that is not permitted to be taken with the antiretroviral drugs they have been assigned to receive
• Patients with cancer requiring treatment with anti-cancer medication or radiation treatment.
• Patients known to be sensitive or allergic to any of the antiretroviral drugs to be given during the study or to the any ingredients in those drugs.
• The following exclusion criteria will be at the judgment of the investigator (researcher in charge of the study at the trial site). - Patients with certain clinical or laboratory abnormalities - Patients with certain conditions, infections, illness, or drug toxicity - Patient's use of alcohol and/or drug or substance abuse that would likely result in the patient being unreliable in fulfilling the conditions of the study. - Patients with a psychological illness or condition that may interfere with the their ability to understand the requirements of the study - Patients considered to be unreliable and unlikely to stay on the course of therapy

Please reference Study ID Number: RLI-ML18413      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

California
      Berkley,  California,  94705,  United States
District of Columbia
      Washington,  District of Columbia,  20009,  United States
Florida
      Vero Beach,  Florida,  32960,  United States
Missouri
      St. Louis,  Missouri,  63139,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  19107,  United States
Puerto Rico
      Ponce,  00717,  Puerto Rico

Study ID Numbers:  ML18413
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  March 4, 2005
ClinicalTrials.gov Identifier:  NCT00105079
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08