BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

NCT00272779 | Completed Phase 3 Results DMC

• 1 other identifier: AI424-138
• Study Type: interventional
• Target: 1,057
• Locations: 27 countries
• Sites: 75

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

Conditions

HIV Infections

Keywords

HIV; Treatment Naive

Outcome Measures

Primary Outcomes (29)

• Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48

  HIV RNA \< 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.

  Baseline (Day 1) and Week 48

• Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4

  Cmax was derived from plasma concentration versus time data.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.

• Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

  AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

  Cmin was derived from the plasma concentration versus time data.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

  Tmax was derived from the plasma concentration versus time data.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

  T-half was derived from the plasma concentration versus time data.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4

  EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4

  IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Cmax of RTV at Week 4

  Cmax was derived from plasma concentration versus time data.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• AUC (0-24) of RTV at Week 4

  AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Cmin of RTV at Week 4

  Cmin was derived from plasma concentration versus time data.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Cmax of Tenofovir at Week 4

  Cmax was derived from plasma concentration versus time data.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Cmin of Tenofovir at Week 4

  Cmin was derived from plasma concentration versus time data.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• AUC (TAU) of Tenofovir at Week 4

  AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

• Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96

  Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.

  Baseline (Day 1) and Week 96.

• Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis

  19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type \[WT, common homozygous\].

  Baseline visit

• Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in VAT Associated With RETN_730

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).

  Baseline (Day 1), Week 48, and Week 96.

• Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980

  The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).

  Baseline (Day 1), Week 48, and Week 96.

Secondary Outcomes (59)

• Number of Participants With HIV RNA < 400 c/mL at Week 48

  Baseline (Day 1) and Week 48

• Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)

  Baseline (Day 1) and Week 48

• Reduction of log10 HIV RNA Levels From Baseline to Week 48

  Baseline (Day 1) and Week 48

• Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48

  Baseline (Day 1) and Week 48.

• Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48

  Baseline (Day 1) and Week 48

Study Arms (2)

Atazanavir (ATV) + Ritonovir (RTV)

ACTIVE COMPARATOR

Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.

Drug: ATV; Drug: RTV; Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet

Lopinavir (LPV) + RTV

ACTIVE COMPARATOR

Participants were administered an oral dose of LPV 400 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of LPV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.

Drug: RTV; Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet; Drug: LPV

Interventions

ATV DRUG

300mg Oral capsules for 96 weeks

Also known as: Atazanavir, Reyataz, BMS-232632

Atazanavir (ATV) + Ritonovir (RTV)

RTV DRUG

100mg Oral Capsules for 96 weeks

Atazanavir (ATV) + Ritonovir (RTV); Lopinavir (LPV) + RTV

Tenofovi-Emtricitabine (TDF/FTC) tablet DRUG

One tablet with 300 mg - 200 mg once a day for 96 weeks.

Atazanavir (ATV) + Ritonovir (RTV); Lopinavir (LPV) + RTV

LPV DRUG

400 mg (3 133mg capsules) BID for 96 weeks

Lopinavir (LPV) + RTV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV RNA ≥5000 c/ml

You may not qualify if:

• Any antiretroviral therapy within 30 days prior to screening;
• Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the study;
• WOCBP using a prohibited contraceptive method
• WOCBP who are pregnant or breastfeeding;
• Women with a positive pregnancy test on enrollment or prior to study drug administration;
• Presence of a newly diagnosed HIV-Related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
• Suspected primary (acute) HIV infection;
• Prior antiviral therapy (\>30 days of NRTI and/or \>7 days of non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within 30 days prior to screening; some exceptions are allowed for ARV therapy in use for Mother-to-child transmission;
• Participants with Cushing's syndrome;
• Untreated hypothyroidism or hyperthyroidism. A participant who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the thyroid stimulating hormone (TSH) performed within 30 days of screening is within normal drug range;
• Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or expected need for such therapy at the time of enrollment; or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4;
• Participants with obstructive liver disease;
• Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;
• Proven or suspected acute hepatitis in the 30 days prior to study entry;
• Intractable diarrhea (≥6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (79)

Local Institution

Phoenix, Arizona, United States

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Laguna Beach, California, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Orlando, Florida, United States

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Huntersville, North Carolina, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Capital Federal, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, Argentina

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Córdoba, Argentina

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Darlinghurst, New South Wales, Australia

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Carlton, Victoria, Australia

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South Yarra, Victoria, Australia

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Vienna, Austria

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Bruges, Belgium

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Ghent, Belgium

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Curitiba, Paraná, Brazil

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Recife, Pernambuco, Brazil

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Campinas, São Paulo, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, Santiago Metropolitan, Chile

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Bogotá, Colombia

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San José, Costa Rica

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Santo Domingo, Dominican Republic

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Nice, France

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Paris, France

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Villejuif, France

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Berlin, Germany

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Bonn, Germany

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Cologne, Germany

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Hamburg, Germany

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Guatemala City, Guatemala

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Kowloon, Hong Kong

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Jakarta, Indonesia

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Genova, Italy

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Milan, Italy

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Roma, Italy

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Torino, Italy

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Guadalajara, Jalisco, Mexico

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Zapopal, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Chihuaha, Mexico

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Durango, Mexico

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San Luis Potisi, Mexico

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Maastricht, Netherlands

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Utrecht, Netherlands

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Panama City, Panama

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Lima, Peru

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Lisbon, Portugal

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Ponce, Puerto Rico

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San Juan, Puerto Rico

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Singapore, Singapore

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Port Elizabeth, Eastern Cape, South Africa

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Meadowdale, Gauteng, South Africa

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Westdene, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Mowbray, Western Cape, South Africa

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Parow, Western Cape, South Africa

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Rugby, Western Cape, South Africa

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Málaga, Spain

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Kaohsiung City, Taiwan

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Taipei, Taiwan

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Chiang Mai, Thailand

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Khonkaen, Thailand

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London, Greater London, United Kingdom

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Manchester, Greater Manchester, United Kingdom

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Related Publications (5)

• Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Wirtz V, Lataillade M, Absalon J, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):323-32. doi: 10.1097/QAI.0b013e3181c990bf.

  PMID: 20032785 BACKGROUND

• Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Thiry A, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008 Aug 23;372(9639):646-55. doi: 10.1016/S0140-6736(08)61081-8.

  PMID: 18722869 BACKGROUND

• Zhu L, Liao S, Child M, Zhang J, Persson A, Sevinsky H, Eley T, Xu X, Krystal M, Farajallah A, McGrath D, Molina JM, Bertz R. Pharmacokinetics and inhibitory quotient of atazanavir/ritonavir versus lopinavir/ritonavir in HIV-infected, treatment-naive patients who participated in the CASTLE Study. J Antimicrob Chemother. 2012 Feb;67(2):465-8. doi: 10.1093/jac/dkr490. Epub 2011 Nov 25.

  PMID: 22121190 DERIVED

• Uy J, Yang R, Wirtz V, Sheppard L, Farajallah A, McGrath D. Treatment of advanced HIV disease in antiretroviral-naive HIV-1-infected patients receiving once-daily atazanavir/ritonavir or twice-daily lopinavir/ritonavir, each in combination with tenofovir disoproxil fumarate and emtricitabine. AIDS Care. 2011 Nov;23(11):1500-4. doi: 10.1080/09540121.2011.565033. Epub 2011 Jul 7.

  PMID: 21732894 DERIVED

• Squires KE, Johnson M, Yang R, Uy J, Sheppard L, Absalon J, McGrath D. Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 96 weeks in the CASTLE study. J Antimicrob Chemother. 2011 Feb;66(2):363-70. doi: 10.1093/jac/dkq457. Epub 2010 Dec 9.

  PMID: 21148235 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate; Tablets

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

ClinicalTrials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: November 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: October 1, 2008
• Last Updated: May 9, 2011
• Results First Posted: May 9, 2011

Record last verified: 2011-04

Locations

ID (1); FR (3); ES (4); DO (1); PE (1); NL (2); ZA (9); DE (4); BR (5); IT (4); PT (1); PR (2); HK (1); SG (1); GU (1); CA (2); AU (1); US (8); ME (7); PA (1); AR (5); BE (2); CO (1); TW (2); TH (2); CL (2); GB (2)