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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation T69D

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There are 2 clinical trials

Clinical Trials


1 A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects

Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be tested to determine if new drug combinations have increased effectiveness in treating HIV. The purpose of this study is to test the safety, tolerability, and effectiveness of four different regimens in HIV-infected adults who have never taken anti-HIV drugs.

NCT00118898
Conditions
  1. HIV Infections
Interventions
  1. Drug: Abacavir/Lamivudine
  2. Drug: Atazanavir
  3. Drug: Efavirenz
  4. Drug: Emtricitabine/Tenofovir disoproxil fumarate
  5. Drug: Ritonavir
  6. Drug: Abacavir/Lamivudine placebo
  7. Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo
MeSH:HIV Infections

Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.. Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.. AIDS-defining illnesses were defined per CDC category C definition. --- T69D ---

Primary Outcomes

Description: Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.

Measure: Time From Randomization to Virologic Failure

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.

Measure: Time From Treatment Dispensation to a Grade 3/4 Safety Event

Time: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.

Description: Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Time From Treatment Dispensation to Treatment Modification

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Secondary Outcomes

Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Measure: The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

Time: At Weeks 48 and 96

Measure: Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

Time: At Weeks 48 and 96

Description: Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).

Measure: Change in CD4 Count (Cells/mm3) From Baseline

Time: At Weeks 48 and 96

Description: Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.

Measure: Number of Participants With Virologic Failure and Emergence of Major Resistance

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details. http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm

Measure: Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Total Cholesterol Level From Baseline

Time: At Weeks 48 and 96

Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline

Time: At Weeks 48 and 96

Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline

Time: At Weeks 48 and 96

Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Triglyceride Level From Baseline

Time: At Weeks 48 and 96

Other Outcomes

Description: Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.

Measure: Amount of Study Follow-up

Time: Follow-up time was variable, median follow-up was 138 weeks

Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.

Measure: Number of Participants With Virologic Failure

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.

Measure: Cumulative Probability of Not Experiencing Virologic Failure

Time: At week 48 and 96

Description: Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.

Measure: Number of Participants With a Grade 3/4 Safety Event

Time: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks

Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.

Measure: Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event

Time: At week 48 and 96

Description: Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Number of Participants With Treatment Modification

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Cumulative Probability of Not Experiencing Treatment Modification

Time: At week 48 and 96

Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Number of Participants With Regimen Failure

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Cumulative Probability of Not Experiencing Regimen Failure

Time: At week 48 and 96

2 Open Label, Randomized Trial of TDF/FTC+Raltegravir Vs. TDF/FTC+Efavirenz in HIV-1-Infected Women: Differential Effects on Viral Suppression/Reservoir, & Immune Parameters in Different Compartments, Including Gut & Genital Tract

Raltegravir not only has a unique mechanism of action, but may also have other unique effects on suppression of viral replication, viral reservoir, and immune reconstitution in blood and other important compartments. This may in part be due to the pharmacokinetics of Raltegravir in blood and gut tissue. Efavirenz will be the comparator antiretroviral drug in this study, with both drugs being used as part of a three-drug regimen with tenofovir and emtricitabine. The primary objectives are to determine differences in the effects of 2 anti-retroviral regimens, Raltegravir + Truvada versus Atripla, with respect to: 1. Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ hybridization). 2. Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract. 3. Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine profiles. The secondary objective is to determine the pharmacokinetics of Raltegravir in blood and gut tissue; relative tissue/compartment penetration compared to Efavirenz.

NCT00984152
Conditions
  1. HIV-1 Infections
Interventions
  1. Drug: TDF/FTC Once-Daily + Raltegravir 400 mg Orally Twice-Daily
  2. Drug: TDF/FTC + Efavirenz (Atripla) Once-Daily

Exclusion Criteria: 1. Menopausal (may affect quantity of genital tract secretions) or any serious illness that requires treatment and/or hospitalization until the patient completes therapy 2. Any active infection, including co-infection with hepatitis B or C 3. Any neoplasm 4. Immunosuppressive therapy 5. Requirement for any medications that are prohibited by any of the study treatments 6. Significant liver or renal dysfunction 7. Baseline resistance to any of the study drugs by genotypic testing - NRTI: M41L, K65 R, D76N, T69D, K70R, L74V/I, y115F, Q151M, M184V, L210W, T215any, K219Q/E - NNRTI:L100I, K103N, V106A/M, V108I, Y181C/I, Y188C/L/H, G190anyA/S 8. Alcohol or substance abuse problems or psychiatric conditions that impair the ability of the subject to comply with the study protocol Inclusion Criteria: 1. Eligible subjects will be antiretroviral naïve (< 7 days of HAART at any time prior to entry) with plasma HIV-1 RNA > 50,000 copies/mL (obtained within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent) and moderate immune suppression within 90 days prior to study entry. --- M41L --- --- D76N --- --- T69D ---

Exclusion Criteria: 1. Menopausal (may affect quantity of genital tract secretions) or any serious illness that requires treatment and/or hospitalization until the patient completes therapy 2. Any active infection, including co-infection with hepatitis B or C 3. Any neoplasm 4. Immunosuppressive therapy 5. Requirement for any medications that are prohibited by any of the study treatments 6. Significant liver or renal dysfunction 7. Baseline resistance to any of the study drugs by genotypic testing - NRTI: M41L, K65 R, D76N, T69D, K70R, L74V/I, y115F, Q151M, M184V, L210W, T215any, K219Q/E - NNRTI:L100I, K103N, V106A/M, V108I, Y181C/I, Y188C/L/H, G190anyA/S 8. Alcohol or substance abuse problems or psychiatric conditions that impair the ability of the subject to comply with the study protocol HIV-1 Infections This is a phase III, prospective, randomized (1:1), multicenter, open label study comparing the effects of two HAART regimens: - Arm A: Raltegravir 400 mg PO BID + TDF/FTC (Truvada, 300/200 mg) One PO Daily - Arm B: Efavirenz + TDF/FTC (Atripla) Once PO Daily The following local sites: Mt. --- M41L --- --- D76N --- --- T69D ---

Primary Outcomes

Measure: Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ hybridization)

Time: 48 weeks

Measure: Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract

Time: 48 weeks

Measure: Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine profiles

Time: 48 weeks

Secondary Outcomes

Measure: Determine the pharmacokinetics of Raltegravir in blood and gut tissue; relative tissue/compartment penetration compared to Efavirenz

Time: 48 weeks


HPO Nodes