--- title: Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily nct_id: NCT00002241 overall_status: UNKNOWN phase: PHASE2 sponsor: Merck Sharp & Dohme LLC study_type: INTERVENTIONAL primary_condition: HIV Infections countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00002241.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00002241" ct_last_update_post_date: 2005-06-24 last_seen_at: "2026-05-12T06:20:41.815Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily **Official Title:** A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals **NCT ID:** [NCT00002241](https://clinicaltrials.gov/study/NCT00002241) ## Key Facts - **Status:** UNKNOWN - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 80 - **Lead Sponsor:** Merck Sharp & Dohme LLC - **Conditions:** HIV Infections - **CT.gov Last Update:** 2005-06-24 ## Brief Summary The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood. ## Detailed Description Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful. ## Eligibility - **Minimum age:** 16 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria Patients may be eligible for this study if they: * Are HIV-positive. * Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more. * Are age 16 or older (consent of a parent or guardian required if under 18). * Agree to practice abstinence or use barrier methods of birth control (such as condoms). * Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.) Exclusion Criteria Patients will not be eligible for this study if they: * Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed). * Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV). * Have changed their medications in the last 2 weeks. * Are allergic to IDV, RTV, d4T, or 3TC. * Have used certain medications (see the technical summary for more detail). * Are pregnant or breast-feeding. ``` ## Interventions - **Indinavir sulfate** (DRUG) - **Ritonavir** (DRUG) - **Lamivudine** (DRUG) - **Stavudine** (DRUG) ## Locations (18) - Univ of Alabama at Birmingham, Birmingham, Alabama, United States - Apogee Med Group, San Diego, California, United States - Univ of California at San Francisco Gen Hosp, San Francisco, California, United States - HIV Institute / Davies Med Ctr, San Francisco, California, United States - Kaiser Foundation Hospital, San Francisco, California, United States - Univ of Miami School of Medicine, Miami, Florida, United States - AIDS Research Alliance - Chicago, Chicago, Illinois, United States - Tulane Univ School of Medicine, New Orleans, Louisiana, United States - CRI New England, Brookline, Massachusetts, United States - SUNY Health Sciences Ctr, Brooklyn, New York, United States - Chelsea Village Med Ctr, New York, New York, United States - Liberty Med Group, New York, New York, United States - St Lukes / Roosevelt Hosp / HIV Center, New York, New York, United States - Mount Sinai Med Ctr, New York, New York, United States - Bronx Lebanon Hosp Ctr, The Bronx, New York, United States - Montefiore Med Ctr, The Bronx, New York, United States - Mark Watkins, Philadelphia, Pennsylvania, United States - Univ of Texas / Thomas Street Clinic, Houston, Texas, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.univ of alabama at birmingham|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.apogee med group|san diego|california|united states` — added _(2026-05-12)_ - `locations.univ of california at san francisco gen hosp|san francisco|california|united states` — added _(2026-05-12)_ - `locations.hiv institute / davies med ctr|san francisco|california|united states` — added _(2026-05-12)_ - `locations.kaiser foundation hospital|san francisco|california|united states` — added _(2026-05-12)_ - `locations.univ of miami school of medicine|miami|florida|united states` — added _(2026-05-12)_ - `locations.aids research alliance - chicago|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.tulane univ school of medicine|new orleans|louisiana|united states` — added _(2026-05-12)_ - `locations.cri new england|brookline|massachusetts|united states` — added _(2026-05-12)_ - `locations.suny health sciences ctr|brooklyn|new york|united states` — added _(2026-05-12)_ - `locations.chelsea village med ctr|new york|new york|united states` — added _(2026-05-12)_ - `locations.liberty med group|new york|new york|united states` — added _(2026-05-12)_ - `locations.st lukes / roosevelt hosp / hiv center|new york|new york|united states` — added _(2026-05-12)_ - `locations.mount sinai med ctr|new york|new york|united states` — added _(2026-05-12)_ - `locations.bronx lebanon hosp ctr|the bronx|new york|united states` — added _(2026-05-12)_ - `locations.montefiore med ctr|the bronx|new york|united states` — added _(2026-05-12)_ - `locations.mark watkins|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.univ of texas / thomas street clinic|houston|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00002241.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00002241* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*