Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00071760
First received: October 30, 2003
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus
Drug: GW433908
Drug: ritonavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 48 Week, Phase II, Open-label, 2-cohort, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of GW433908 and GW433908/RTV When Administered to HIV-1 Infected Protease Inhibitor (PI) Naive and PI-experienced Pediatric Subjects Aged 4 Weeks to <2 Years.

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Plasma Amprenavir (APV) AUC (0-tau[τ]) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where "τ" is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr.

  • Plasma APV Cmax [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The maximum concentration at steady state (Cmax) was measured.

  • Plasma APV Cτ [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.

  • Plasma APV CL/F Following Dosing Expressed in mL/Min/kg [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.

  • Plasma APV CL/F Following Dosing Expressed in mL/Min [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).

  • Plasma Unbound APV Cτ [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or "free" APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state.

  • Plasma Unbound APV Percent Protein Binding (%Cτ) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.

  • Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48 [ Time Frame: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in ALT and AST was calculated as the value at the indicated time point minus the value at Baseline.

  • Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48 [ Time Frame: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium was calculated as the value at the indicated time point minus the value at Baseline.

  • Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48 [ Time Frame: Baseline (Day 1) and Weeks 4, 12, 24, and 48 ] [ Designated as safety issue: No ]
    Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.

  • Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities [ Time Frame: Baseline (Day 1) until Week 48 ] [ Designated as safety issue: No ]
    TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Neutropenia is a decrease (d) in the number of Ns, d/increase (I) in glucose is hypo (Hp)/hyper (Hy)glycemia, in potassium is Hp/Hykalemia, and in sodium is Hp/Hynatremia. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.

  • Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE) [ Time Frame: Baseline (Day 1) until Week 48 ] [ Designated as safety issue: No ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.

  • Number of Participants Who Permanently Discontinued the Treatment Due to an AE [ Time Frame: Baseline (Day 1) until Week 48 ] [ Designated as safety issue: No ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.


Secondary Outcome Measures:
  • Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation=Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.

  • Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.

  • Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.

  • Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the MSD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.

  • Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.

  • Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline.

  • Number of Participants With the Indicated Virological Outcome at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.).

  • Plasma Ritonavir (RTV) AUC (0-τ) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted PK analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.

  • Plasma RTV Cmax [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The maximum concentration at steady state (Cmax) was measured.

  • Plasma RTV Cτ [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.

  • Plasma RTV CL/F Expressed in mL/Min/kg [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.

  • Plasma RTV CL/F Expressed in mL/Min [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).

  • Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: No ]
    A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.

  • Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: No ]
    A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.

  • Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire [ Time Frame: Weeks 2, 12, 24, and 48 ] [ Designated as safety issue: No ]
    A separate questionnaire were administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Question 5 queried about the number of doses of FPV or RTV missed since the participant's last study visit. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.

  • Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 [ Time Frame: Weeks 2, 24, and 48/premature study discontinuation ] [ Designated as safety issue: No ]
    P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G's perception of the child's assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit.

  • Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 [ Time Frame: Weeks (W) 2, 24, and 48/premature study discontinuation ] [ Designated as safety issue: No ]
    Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian's perception of the child's assessment of the oral suspension (Items: 5=reaction to new medicine [med.]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like.

  • Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.

  • Plasma FPV AUC (0-τ) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.

  • Plasma FPV Cmax and Cτ [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.

  • Plasma FPV CL/F Expressed in mL/Min/kg [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.

  • Plasma FPV CL/F Expressed in mL/Min [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.


Enrollment: 75
Study Start Date: October 2003
Estimated Study Completion Date: June 2021
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A - 4weeks - less than 2 years old (FPV/RTV bid)

Cohort 2A - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID)

Cohort 1A - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID)

Drug: GW433908
Fosamprenavir suspension bid
Drug: ritonavir
Ritonavir solution bid
Other Names:
  • GW433908
  • ritonavir
Experimental: Arm B- 4weeks - less than 2 years old (FPV bid)

Cohort 2B - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID)

Cohort 1B - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID)

Drug: GW433908
Fosamprenavir suspension bid

Detailed Description:

A 48 week, Phase II, open-label, 2-cohort, multicenter study to evaluate the pharmacokinetics, safety, tolerability and antiviral activity of GW433908 and GW433908/RTV when administered to HIV-1 infected protease inhibitor (PI) naive and PI-experienced pediatric subjects aged 4 weeks to <2 years.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 4 weeks to <2 years of age. Cohort 1 (6 months - <2 years): Subjects must be <2 years of age at the Week 2 visit therefore the maximum age at screening is 22 months.

Cohort 2 (4 weeks - <6 months): Subjects must be <6 months of age at the Week 2 visit, therefore the maximum age at screening is 4 months for entry into this cohort.

  • Parent or legal guardian is willing and able to provide written informed consent for the subject to participate in the trial.
  • Screening plasma HIV-1 RNA level >=400copies/mL.
  • Subjects who, in the investigator's opinion, and following viral resistance testing if conducted, are able to construct an active Nucleoside Reverse Transcriptase Inhibitor (NRTI) backbone regimen consisting of 2 NRTIs.
  • Subjects must meet one of the following criteria:

Therapy-naïve or PI-naïve subjects (defined as having received less than one week of any PI).

PI-experienced subjects defined as having prior experience with no more than three PIs. Prior RTV-boosted PI therapy will be considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.

Exclusion Criteria:

  • Prior history of having received APV.
  • Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) therapy within 14 days prior to study drug administration (single or multiple dose) or anticipated need for concurrent NNRTI therapy during the study period.
  • PI therapy within 5 days prior to study drug administration (applicable only for subjects undergoing single dose visits)
  • Subjects and/or parents/legal guardians who, in the investigator's opinion, are not able to comply with the requirements of the study.
  • Subject is in the initial acute phase of a Centers for Disease Control and Prevention (CDC) Clinical Category C event or infection (per 1994 classification) at Baseline. Subject may be enrolled provided they are receiving treatment for the infections, such treatment not being contraindicated with FPV, and subjects are clinically improving at the Baseline visit.
  • Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication.
  • Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia, diabetes, cardiac dysfunction, hepatitis, or clinically relevant pancreatitis) which, in the opinion of the investigator, might compromise the safety of the subject.
  • Any acute laboratory abnormality at screen which, in the opinion of the investigator, should preclude the subject's participation in the study of an investigational compound. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the screening window. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation.
  • Grade 3 or higher (>10x ULN) serum aminotransferase levels (alanine aminotransferase, ALT and/or aspartate aminotransferase, AST) within 28 days prior to study drug administration and / or clinically relevant hepatitis within the previous 6 months.
  • Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or an anticipated need for such treatment within the study period.
  • Treatment with immunomodulating agents (e.g., systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (e.g., hydroxyurea or foscarnet) within 28 days of study drug administration.
  • Treatment with any of the following medications within 28 days prior to receiving study medication or the anticipated need during the study:

Amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam, lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone, propoxyphene, quinidine, simvastatin, terfenadine, and triazolam (these drugs have been excluded for safety reasons).

Carbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort, (these drugs have been excluded because they have the potential to decrease plasma protease inhibitor concentrations).

  • Treatment with other investigational drugs/therapies within 28 days prior to receiving study medication (note: treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis in consultation with the sponsor).
  • History of drug or other allergy which, in the opinion of the investigator, contraindicates participation in the trial or known hypersensitivity to any study medications (e.g. documented hypersensitivity to a nucleoside analogue).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071760

Locations
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27705
Argentina
GSK Investigational Site
Buenos Aires, Argentina, 1405
Mexico
GSK Investigational Site
Mexico, Mexico, 6720
GSK Investigational Site
Mexico, D.F., Mexico, 06720
Portugal
GSK Investigational Site
Almada, Portugal, 2805-267
GSK Investigational Site
Amadora, Portugal, 2700
GSK Investigational Site
Lisboa, Portugal, 1649-035
Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico, 00935
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105275
GSK Investigational Site
Moscow, Russian Federation, 129110
GSK Investigational Site
St. Petersburg, Russian Federation, 196645
South Africa
GSK Investigational Site
Durban, KwaZulu- Natal, South Africa, 4013
GSK Investigational Site
Parow Valley, Western Province, South Africa, 7505
GSK Investigational Site
Soweto, South Africa, 2013
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00071760     History of Changes
Other Study ID Numbers: APV20002
Study First Received: October 30, 2003
Results First Received: March 2, 2012
Last Updated: May 8, 2014
Health Authority: Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
pediatrics
ritonavir
amprenavir
AGENERASE
HIV
Lexiva
protease inhibitors
HIV Infection
fosamprenavir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Fosamprenavir
HIV Protease Inhibitors
Protease Inhibitors
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014