To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Saquinavir	Phase I

Further Study Details: 

Expected Total Enrollment:  80

Patients are randomly assigned to one of the four treatment groups as follows: Group 1: 10 patients receive saquinavir HGC. Group 2: 10 patients receive saquinavir SGC. Group 3: 30 patients receive saquinavir SGC at an intermediate dose. Group 4: 30 patients receive saquinavir SGC at the highest study dose. Upon completion of the initial 4 weeks, all patients may have the option to continue their originally-assigned therapy as monotherapy unless significant drug toxicity intervenes. If the analysis of the initial 4 week data identifies an optimal dose of saquinavir SGC, patients may have the option to change to this optimal dose in a treatment extension phase of the protocol. Patients in this extension phase may choose to remain on monotherapy unless they experience significant drug toxicity, their CD4 count or HIV-RNA levels return to baseline, until saquinavir is approved by the FDA or study termination, whichever comes first. NOTE: A washout >= 28 days is required for patients on antiretroviral therapy.

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

Criteria

Inclusion Criteria

Patients must have:

• CD4 count of 100 to 500 cells/mm3.
• Greater than 20,000 HIV-RNA copies/ml.

Exclusion Criteria

Prior Medication: Excluded: Prior treatment with protease inhibitors. Required:

• Less than 8 weeks prior antiretroviral treatment (For at least 25% of patients).
• At least 8 weeks prior antiretroviral treatment (For at least 25% of patients).

Alabama
      Univ of Alabama at Birmingham / 1917 Rsch Cln, Birmingham,  Alabama,  35294,  United States
California
      Pacific Oaks Med Group / Research & Scientific Investiga, Sherman Oaks,  California,  91403,  United States
      Davis Med Ctr, San Francisco,  California,  94114,  United States
      Mt Zion Hosp of UCSF / HIV Research Ctr, San Francisco,  California,  94115,  United States
Louisiana
      Tulane Univ Med Ctr / Infectious Diseases Sect, New Orleans,  Louisiana,  70112,  United States
Massachusetts
      New England Med Ctr, Boston,  Massachusetts,  02111,  United States
Missouri
      Kansas City AIDS Research Consortium, Kansas City,  Missouri,  64108,  United States
New York
      Harkness Pavilion, New York,  New York,  10032,  United States
Oregon
      Oregon Health Sciences Univ, Portland,  Oregon,  97201,  United States
Texas
      Univ of Texas Med Branch / Virology Clinic, Galveston,  Texas,  775550882,  United States

Study ID Numbers:  229M; NV15107
Record last reviewed:  July 1997
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002383
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08