None listed
Conditions
Interventions
Regimen A Type of group
800 mg indinavir sulfate twice daily plus ritonavir 100 mg twice daily plus two new NRTIs for 48 weeks
Group name:Regimen B Type of group
Nelfinavir 1250 mg twice daily plus two new NRTIs for 48 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is a virgin of the protease inhibitor. • If the patient has experience with NRTI or NNRTI, he / she meets the other enrollment criteria and has 2 new NRTIs available for therapeutic use. • The patient is a man or woman with a minimum age of 18 years. If the patient is a potentially fertile woman, she must prove a negative pregnancy test (HCG) within 30 days prior to enrollment in the study and then use appropriate birth control methods such as barrier contraception or as defined the principal investigator and a follow-up urine pregnancy test will be conducted throughout the study. Oral contraceptives or depo-progesterone should not be used as the only method of birth control. Patients who become pregnant during the study will be removed from the study. • The patient has documentation of being seropositive for HIV-1 determined by means of a positive ELISA test and a confirmatory test such as Western blot (using conventional criteria) or HIV viral RNA susceptible of measurement by PCR or bDNA (using conventional criteria) , if Western blot is not decisive. • The patient has a CD4 cell count of> 100 cells / mm3 within 30 days prior to the study treatment phase. • The patient has 2 documented consecutive viral RNA levels of> 20,000 copies / mL by means of PCR within 30 days of the study treatment phase. If the patient changes his treatment regimen after this viral RNA result, the test will be repeated. • The following laboratory values ​​were obtained within 30 days of the study treatment phase: Hemoglobin> 8.0 g / dL, Absolute neutrophil count> 850 / mm3, Platelet count> 75,000 / mm3, Creatinine <2.0 mg / dL, total serum bilirubin within normal limits; alkaline phosphatase <2.0 X normal upper limit; AST (SGOT), ALT (SGPT) <5.0 X normal upper limit. (The patient with stable abnormalities in these laboratory parameters can possibly enroll after talking with the clinical monitor). • The patient has a chest x-ray without signs of disease or active puimonar infection within 30 days of treatment in this study.
Exclusion criteria
Exclusion criteria: • The patient is pregnant or is breastfeeding (Patients who become pregnant during the study will be removed from it). • The patient has previously used protease inhibitor. • The patient requires antiretroviral agents, including foscamet, except for those specified in the protocol. • The patient requires experimental agents (including unauthorized antiviral agents), immunomodulatory agents (GMCSF, IL-2, interferon, chronic use of corticosteroids, etc.), filgastrin (G-CSF) or erythropoietin within 30 days prior to treatment in this studio. (Erythropoietin or filgastrin will be allowed, when necessary, only after beginning study therapy). • The patient is expected to use any immunosuppressive therapy for malignancy during treatment in this study. (This does not exclude patients with cutaneous Kaposi sarcoma who do not require systemic immunosuppressive therapy at the time of enrollment, intralesional or localized electron beam therapy is allowed for Kaposi´s cutaneous sarcoma). • The patient requires rifabutin, rifampicin, ketoconazole, itraconazole, foscamet, disulfiram, or other drugs that produce reactions equal to disulfiram (eg, metronidazole), meperidine, propoxyphene, piroxicam, amiodarone, alprazolam, encainide, flecainide, propafenone, quinidine, bupropion , bepridil, clozapine, pimozide, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam, zolpidem, simvastatin, lovastatin, terfenadine, astemizole, cisapride and medications derived from ergot. • The patient has considerable hypersensitivity or another contraindication to any of the components of the study drugs. • The patient has a diagnosis of acute hepatitis due to any cause. (Patients with chronic hepatitis, including chronic hepatitis B surface antigenemia, can enter the study as long as they undergo stable liver function tests and meet all inclusion criteria). The patient has acute exacerbation of chronic hepatitis or in the opinion of the investigator has evidence of deficiency of hepatic synthetic function such as TP (thromboplastin time) and TFT (partial thromboplastin time) prolonged. • The patient has an opportunistic infection or active malignancy. • The patient has problems with alcohol or substance abuse that in the opinion of the investigator would interfere with the patient´s compliance or safety. • The patient has any condition or history of diseases that in the opinion of the investigator could confuse the results of the study or represent an additional risk when administering the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:CD4 count should be> 100 cells / mm3. Determination of viral RNA, which should be> 20.00 copies / mL. Measure:Efficacy Timepoints:CD4 cell counts will be determined within 30 days prior to the start of the study and will also be determined before treatment (Day 1), and at each subsequent clinical visit and after the study visit. Two consecutive determinations of viral RNA will be made within 30 days prior to the start of the study and will also be determined before treatment (Day 1), and at each subsequent clinical visit and at the subsequent study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse experiences will be monitored. Also, any serious adverse event, any significant medical event, specific adverse events of the study and adverse events that result in the discontinuation of the study medication will be recorded, in each of the examinations, in the Adverse Event Case Report Forms . Measure:Safety Timepoints:During the whole study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed